QA Director Resume Samples

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D Lueilwitz

Dax

Lueilwitz

358 Laila Lane

Boston

+1 (555) 743 1792

358 Laila Lane

Boston

Phone

p +1 (555) 743 1792

Experience Experience

Los Angeles, CA

QA Director

Los Angeles, CA

Greenfelder, Schinner and Ebert

Los Angeles, CA

QA Director

Direct, motivate, develop and manage performance of the management team and key staff
Working knowledge of the principles of manufacturing management
Manage relationship with business partners and vendors; interface and maintain communications with it and business management. Monitor business and technology developments and provide on-time response and support
Direct, manage and deliver large, complex, mission critical application development project
Works closely with NPD (new product Development), PCD (Product Concept Development), TPD (Technical Packaging Development) IC (Industrial Chemistry) and R&D teams to put QA into Design (FMEA)
Provide consulting expertise to projects of various size and complexity, promoting and developing testing best practices and enterprise wide test strategies
Direct communications and decisions to the business and technology executives by analyzing portfolio business challenges and provide input to formulate a recommended portfolio direction, changes to executives

New York, NY

QA Director, Revenue Test Team

New York, NY

Buckridge and Sons

New York, NY

QA Director, Revenue Test Team

Test strategy, development, and maintenance of test assets (functional, performance, and automation)
Manage the assigned platform and revenue pricing application domains through
Collaborate closely with the development team to analyze, debug, and resolve any testing-related issues
Implement and manage relevant quality processes to ensure business and service objectives are met
Provide support and consultation to other application teams in relation to assigned domains
Provide technology and product research, evaluation and impact analysis
Test planning and design

present

Houston, TX

Bicep Technology Horizontal QA Director

Houston, TX

Bauch, Gutkowski and Rodriguez

present

Houston, TX

Bicep Technology Horizontal QA Director

present

Create communication artefacts for senior management providing transparency on key delivery success factors, delivery risk
Develop and maintain a forward looking “radar” on critical activities, and associated risks and issues for early management attention and resolution
Creation, completion and management of the technology quality assurance framework for BICEP
Develop comprehensive front to back reporting and pro-actively manage / escalate key Tech risks and issues as they emerge
Reporting, governance and stakeholder management
Governance and oversight of the BICEP wide Technology delivery for a particular set of Horizontals/Verticals (e.g. technology Horizontal or CSO/Data Management)
Engage with the CCO Centre of Excellence to understand objectives, processes and templates to follow with the aim of supporting their agenda and de-risking delivery plans

Education Education

Bachelor’s Degree in Computer Science

Loyola Marymount University

Bachelor’s Degree in Computer Science

Skills Skills

Highly knowledgeable with SDLC
Strong working knowledge of GMPs and/or FDA/ISO guidelines for manufacturing of Cosmetic and related products
Solid managerial experience in Quality in the manufacture of Cosmetics or related products
Ability to successfully identify, assess & manage risk proactively & be accountable for actions/tough decisions
Complete all planned Quality & Compliance training within the defined deadlines
Experience of Bioprocess consumable/instrumentation manufacturing
Strong Test Plan, Use case, and test documentation experience
Strong QA Management experience that includes implementing QA Metrics, Processes and Methodology that help measure Development / QA Rate of Improvement
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Ability to communicate effectively in English (both written and oral)

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15 QA Director resume templates

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QA Director, Revenue Test Team Resume Examples & Samples

Lead a team consisting of regular staff, contractors, and consultants/vendors located at different geographical locations
Able to independently manage test teams for large multi-year projects with teams in US, Singapore, and India
Manage the assigned platform and revenue pricing application domains through
Test planning and design
Test strategy, development, and maintenance of test assets (functional, performance, and automation)
Setting of test standards
Implement and manage relevant quality processes to ensure business and service objectives are met
Provide support and consultation to other application teams in relation to assigned domains
Provide technology and product research, evaluation and impact analysis
Strong automation scripting experience to automate front-end and back-end applications, especially using Selenium
Support cross-functional teams in integrated test efforts with other teams
Collaborate closely with the development team to analyze, debug, and resolve any testing-related issues
Develop budgetary forecasts and administer actual operating expenses within cost center. Drive deliverables on time and on budget
Adhere to standard test processes, tools, and metrics to deliver QA solutions for large-scale projects
Understand IT infrastructure, environments, and associated standards and processes, including but not limited to: Release Management, IT Change Control, Technology Auditing, and Software Development Methodologies including agile
At least graduate in Computer Science or equivalent engineering
At least 12+ years of test experience in a commercial environment with strong payment processing and payment gateway, billing and collection applications
Prefer a minimum of 5+ years’ test experience in leading complex global revenue and billing systems
A dynamic leader who has directly managed software testing and quality assurance team members of 30 or more (full time and contractors)
Technical experience in testing, client server, data base (DB2, UDB, SQL, Oracle) data warehousing tools (like Ab Initio), business intelligence reporting (like OBIEE, Micro-strategy) and billing and pricing tools (like Oracle revenue management and billing)
Deep understanding and experience using Scrum software development methodology with practices including continuous integration and test driven development
Experience in coordinating with offshore multi-regional model and if need be, able to work late evenings to attend meetings and calls. At times, it may also need weekend support during release time
Ensures team effectively collaborates with all internal and external stakeholders to quickly manage the resolution of implementation risks and issues and appropriately escalates as needed while providing periodic status updates to senior management
Ability to quickly write utility tools, mock up simulators to test back end systems/engines based on pre-defined messaging ISO, XML standards and XSD schemas
Experience in Unix and mainframe environments with strong shell scripting experience
Advanced user experience in MS Office applications especially Excel and Powerpoint
Experienced creating data driven tests to validate API calls in large J2EE n-tier architectures
Hands-on experience in using HP QualityCenter, IBM ClearQuest and JIRA
Able to independently manage test teams for large multi-year projects with distributed teams globally
Proficiency in articulating test strategy and key acceptance test metrics while prioritizing test scope, based on risk-impact analysis
Demonstrated a track record of achieving tangible results while managing cross-functional teams in a matrix environment with experience in managing expectations and delivery of a highly diverse global workforce
Is comfortable working in an agile environment with work-load of multiple simultaneous deliverables
Must be able to organize and prioritize the workload in order to meet the necessary deadlines
Excellent verbal, written communication, interpersonal and problem solving skills with the ability to lead cross-functional teams
Holds self and team accountable for meeting key metrics and achieving delivery excellence
Resolves performance challenges and addresses employee performance issues
Enhances the capability of the organization by getting the best out of people through performance management, talent assessment, individual development planning and coaching and mentoring
Differentiates, acknowledges and reinforces outstanding performance efforts and rewards high-performing employees
Prefer application development, project management, vendor management experience

QA Director Resume Examples & Samples

QA and Testing : Extensive experience required with Function and Non Functional Testing. Past experience managing a large team of QA testers and ensuring QA delivery is key. Experience with QA strategy for large programs is very relevant
Risk Management--Knowledge of process, tools and techniques for assessing and controlling an organization's exposure (assets, liabilities, reputation…)
Planning: Tactical, Strategic--Ability to contribute to operational (short term), tactical (1 - 2 years) and strategic (3 - 5 years) planning in support of the business plan
Managing Organizational Change--Ability to manage the successful and smooth transition from current to desired culture, practices, structure and overall organizational environment
Budgeting--Knowledge of specific policies and practices for planning and administration of budget
Application Delivery Process--Knowledge of major tasks, deliverables, formal methodologies and disciplines for delivering new or enhanced applications

QA Director Resume Examples & Samples

Establishes annual Quality goals and objectives cascaded from the Corporate and site priorities. Manages QA department resources so that business objectives are cooperatively supported without sacrificing product quality principles
Develop and maintain the Quality System Manual in compliance with requirements of internal QA index (GMP’s) requirements/guidelines
Serves as the primary site contact for Regulatory visits such as UK Regulatory agency. Responds to inspectional observations and any enforcement activities required. Provides regulatory and compliance expertise and interpretation to personnel in situations requiring such expertise
Oversee the GMP audit program and make recommendations for corrective actions to maintain compliance with state agencies
Works with TPMs to resolve quality issues
Reviews and approves all deviation investigation, Change Notices and CAPA processes
Elevate any major issues to QA Corporate (VP QA and Corporate QA Director)
BS in life sciences discipline or other technical degree, ie. Chemistry, biology, or Engineer etc., required
Solid managerial experience in Quality in the manufacture of Cosmetics or related products
Progressive career history in the development and implementation of quality systems with oversight of QA, QC, validation, product release, CAPA . problem solving

QA Director / NA PMI QA Leader Resume Examples & Samples

Motivates, develops, and retains a staff of skilled professionals who contribute to achieving the objectives and goals of the Quality team
Ensures robust quality management systems are established and monitored, by enforcing quality assurance policies and procedures and government requirements
Develops the quality department budget and capital budget. Execute the business plan within budget and look for opportunities to improve the efficiency of the group
Serves as the primary site contact for Regulatory visits such as FDA. Responds to inspectional observations and any enforcement activities required. Provides regulatory and compliance expertise and interpretation to personnel in situations requiring such expertise
Works closely with Coty quality teams to establish and implement quality programs and processes according to Coty corporate policies and procedures
Responsible for Coty QA Index Program implementation and approval of action items assigned to all departments within the organization
Elevate any major issues to Division QA
Manages effective customer complaint handling and assesses whether corrective and preventative action is required
Works closely with NPD (new product Development), PCD (Product Concept Development), TPD (Technical Packaging Development) IC (Industrial Chemistry) and R&D teams to put QA into Design (FMEA)
Takes an active role in qualification of EXO TPMs
Directs daily activities and projects of the regulatory, QA lab, Quality Operations and quality incoming areas
Directly supervises employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
10+ years of managerial experience in Quality in the manufacture of Cosmetics or FMCG products
Progressive career history in the development and implementation of quality systems with oversight of QA, QC, validation, product release, CAPA, Problem solving
Proficient in Microsoft Office (Word, Excel, Access and Outlook) and the ability to use SAP QM

QA Director Resume Examples & Samples

5+ years of experience working as Software QA Manager or Director
Strong QA Management experience that includes implementing QA Metrics, Processes and Methodology that help measure Development / QA Rate of Improvement
5+ years of hands on testing experience
Strong Test Plan, Use case, and test documentation experience
Functional, Integration, User Acceptance and Regression Testing Experience
Prior experience managing Automation and Manual testing teams
Experience selecting and recommending QA Automation tools - (Off the shelf products and Open Source)
Highly knowledgeable with SDLC
Bachelor's in Computer Science or equivalent degree
Proven track record of successfully managing large QA and Testing teams
Project and Program Management experience
CMMI Experience

Software QA Director, IT Resume Examples & Samples

Varies by department. Functional executive identifies documents and communicates technical skill and knowledge requirements for director level jobs
Successful track record designing, developing and executing critical complex projects in more than one area of functional expertise
Ability to establish and maintain effective working relationships at the senior management level across functional groups and business units. Ability to change the thinking of, or gain acceptance from, others in sensitive situations, using influence and preventing damage to the relationship
Strategic Management: Ability to communicate function vision and establish aligned direction and goals for his/her department. Obtains and effectively allocates resources. Creates systems to measure results. Has in-depth understanding of competitor, financial and industry dynamics
Team Development: Actively recruits, retains and develops talent and holds employees accountable for results. Translates vision into action, leads change, and inspires people to get results
Ethics: Deals with others in an honest manner, assures adherence to company policies, and addresses questionable business practices
Customer Focus: Drives and models customer loyalty, manages customer expectations, uses customer feedback to establish department goals, and ensures commitments are met
Communication: Provides others with reliable information, delivers informative and persuasive presentations. Uses good listening skills and negotiates effectively
Normally requires BS Degree or equivalent work experience
5+ years of technical experience as a senior contributor
8+ years of management experience in a similar technical and business environment

QA Director, Quality Site Head Resume Examples & Samples

Ensure timely and complete review and approval of batch records, change controls, deviations, Corrective/ preventative action records, and standard operating procedures to support product disposition and regulatory submissions
Define vision for validation approach for facilities, equipment and processes. Ensure Review and approval support for validation protocols, master plans, and reports
Provide contract manufacturing and contract test lab oversight, help develop and ensure alignment to quality agreements, review and approve CMO/CRO records and reports
Lead and manage the TBU Quality Assurance department
Develop, implement, and optimize key quality initiatives at TBU in alignment with Teva vision and mission statements
Serve as Teva’s Quality Assurance leader in work with Contract Research Organizations (CRO) and Contract Manufacturing Organizations on product implementation and transfer, Quality Agreements, Audits, and support for inspections
Lead the creation of a Quality Culture across all groups at TBU
Lead efforts for TBU and CMO/CRO to prepare for Regulatory filing and inspections to ensure success
Serve as Teva’s Primary Quality Assurance representative in regulatory agency inspections and partner/Teva Audits, and coordinate inspection response strategy

Plant QA Director Resume Examples & Samples

Bachelor's degree in an applied technical discipline required
Based on education and or experience, the ability to provide appropriate technical input and review of design control and validation activities is required
Minimum of ten (10) years of experience in a regulated field, supporting Manufacturing, Quality, and/or Compliance required

QA Director Resume Examples & Samples

5+ years of experience working as Software QA Director
Director level experience is required
Must be currently eligible to work in the US for any employer without sponsorship
Must consent to and successfully clear all required pre-employment screenings (background and substance abuse)
Experience working with government related systems

QA Director UK Resume Examples & Samples

Responsible and accountable for managing Quality of global products supplied by Laboratory Product and F&B BU
Responsible to develop Laboratory Product and F&B specific Quality strategy and goals in line with corporate polices. Responsible for identifying Quality considerations and communicating them to Laboratory Product and F&B senior team. Approve Laboratory Product and F&B manufacturing site’s plan to achieve goals
Implement BU QMS to meet ISO 9001 requirements; identify and implement BU-specific standards to QMS
Maintain supply management processes, including supplier approval, monitoring and development
Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes
Conduct biannual management review meetings and implement BU Audit Program
Implement customer audit program including standard work for customer audits Coordinate responses to customer questionnaires, requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service including Declarations of compliance
Monitor BU-specific regulatory requirements and changes, including labelling requirements, generic product certification, Machinery and Equipment regulations and cGMP principles
Identify Regional & BU-specific Regulatory & Market requirements, comply with corporate escalation and reporting requirements
Ensure compliance with relevant legislation like food contact legislation and CE marking
Accountable for preparation of documentation to support product (RA + Quality management)
Implement 21CFR 170-199 prior sanction, Kosher and Halal and Japanese food sanitation law and any other applicable food contact regulations and standards
Manage BU customer complaint CAPA and NCR processes; adhere to corporate escalation and reporting guidelines
Organize and manage product recalls and field actions including customer notifications, as required
Implement field action risk assessment process in accordance with corporate guidance
Responsible and accountable for managing quarterly global product quality review, and report submissions to Senior management team. The Laboratory Product and F&B Operations leaders to be consulted as needed
Participate in R&D gate meetings as an 'executive sponsor' in projects
Collaborate with Corp QARA and other BUs to identify and share best practices
Maintain key user support resources for QARA software solutions, including Pilgrim
Manage BU-specific QARA organization to meet BU goals; clearly define roles and responsibilities; Aggressively develop talent
Implement, maintain and monitor change control and customer notification procedures
Implement and be accountable for Quality KPI's; drive improvement and report data to Corporate QARA
Prepare and rollout BU-specific training; provide corporate QARA training to BU associates
Educated to Degree level or equivalent in engineering or related science
Several years in a Quality Assurance /Regulatory Affairs role with regional responsibilities
Several years of experience of lean manufacturing and continuous improvement
Several years of experience in Food and Beverage related Industry (producer or supplier)
Previous experience of people management

QA Director Resume Examples & Samples

Leads and drives compliance across sites which includes, but is not limited to the following: Quality Management System, Production & Process Controls, Corrective and Preventative Actions, Design Controls
Responsible and accountable for quality metrics within the business and management review process
Influences product compliance, process development and new product introduction (NPI)
Has the authority to issue concessions and stop production
Represents Quality in program and milestone reviews
Serves on Global or functional Quality Council(s)
Ensures inspection readiness for assigned area of responsibility
Manages budget and headcount as applicable
Provides team leadership and empowerment, facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members
Drives a continuous improvement culture based on data trends/customer feedback
Positive coaching to teams during periods of business change/growth
Foster constructive conflict & collaboration with business partners
Versatility to lead Quality Management systems within regulated & non-regulated environments & support to business integrations as necessary
Conversant in QC testing (including analytical) requirements for incoming chemical/component raw material & finished products
Comprehensive understanding of industry regulations/guidance & health authority regulations (i.e. 21.CFR. 820, 210, 211, 177, 312, 314, 610, 1271; ISO 9001; ISO 13485; ISO 14644; ICH Q1 -12; CBER; EMA/410/01) to support the manufacture & distribution of Bioprocess consumables, instrumentation & Biological materials
Comprehensive understanding of healthcare authority regulatory processes including domestic & internal countries
Interfacing with Global Regulatory Bodies & Health Authorities
Ensure compliance with pharmaceutical customer manufacturing requirements for API’s at stage 1 & 2 clinical trials
Primary Customer QA contact for sites ensuring customer focus & promotion of customer satisfaction
Minimum 12 years Quality Assurance/Regulatory Assurance experience
Minimum 5 years’ experience in the pharmaceutical industry
Minimum 5 years of GMP manufacturing experience
Minimum of 5 years supervisory/management or project leadership experience
Demonstrated significant change management lead expertise
Demonstrated people development, coaching & performance management skills
Demonstrated understanding or aptitude to understand Biopharmaceutical QMS requirements, regulatory requirements & industry guidance, including but not limited to; FDA CFR 21 820, 210, 211 , 312,314, 177, 610, 1271; ISO 9001 & ISO 13485, ICH Q1 - 12, CBER, USP, USP
Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements
Advanced Scientific or Regulatory degree
Demonstrated experience at effectively communicating within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as Six Sigma, DFR, etc
Ability to successfully identify, assess & manage risk proactively & be accountable for actions/tough decisions
Proven track record in performing & leading internal and external audits
Experience of Phase 1/Phase 2 GMP Clinical Trials
Experience of Bioprocess consumable/instrumentation manufacturing
Experience of Biologics manufacturing

Agile Testing Leader / QA Director Resume Examples & Samples

Understand business domain quickly and design a realistic simulation of user behavior for beta rollouts in live stores
Manage the definition of done as it relates to Test Case creation
Institute a process to normalize and collect Test quality and Test exection metrics across teams
Coordinate test activities with release management
Lead definition of test plans in an Agile environment
Define continuous improvement plan for coverage and reducing redundant testing
Lead development of reusable automated test scripts and maintain their compatibility with software as the applications change
Define and execute an automated testing plan with continuous integration
Define performance and load testing plans
Define security testing plans and support PCI compliance initiatives
Properly coach or staff and scale QA organization as needed including web based testing vendors
Bachelor’s Degree in a technical discipline or greater
Experience with Agile testing techniques in a multi team environment with independent ship dates
A rocket ship commander with at least 5 years of Software QA/Agile leadership experience – testing multi-tier software product lines
Strong mastery or deep understanding of prioritizing and managing automated testing
Experience leading testing of SaaS products – i.e. HTTP(S), JSON, Regular Expressions, SQL are household terms
Natural at identifying, troubleshooting, and coming up with a plan of action in a quickly moving product organization
Must be metrics driven and able to set, collect, and present organization specific performance metrics to drive continuous improvement
Experience leading both hardware and software test teams
Hands-on experience with test environment configuration and relationships to Test Plans and Test Cases - is valuable
Experience leading web scripting projects – i.e. Selenium/Appium WebDriver experience
Experience building out a multi-product test organization and staffing software development engineers in test
Experience with managing to a budget and providing yearly forecasts
Experience providing quality metrics on user stories and estimates against requirements
A Bachelor's or Master’s Degree in Computer Science, or an equivalent combination of education and work experience

QA Director Resume Examples & Samples

You cumulate at least five (5) years of experience in management positions in a related field
You cumulate eight (8) years of experience in the heavy industries and eight (8) years of experience in Quality Assurance
Your knowledge of advanced product quality planning (APQP) will be considered as an asset
Your ability to facility Failure Mode and Effect Analysis (FMEA) will be considered as an asset
Your English communication skills are excellent both spoken and written

QA Director Resume Examples & Samples

Ensures books are produced in accordance with the docket, dummy and quality standards following Standard Operating Procedures
Must maintain accurate counts and documentation
Ensures team is informed of and understands job requirements
Ensures proper machine set-up, operation, maintenance and housekeeping
May provide advice, training and guidance to Bindery Operators and Assistants

QA Director Resume Examples & Samples

Technical knowledge in applications using Siebel, Oracle, Thunderhead, FileNet, Pega, SharePoint
Certified in some form of Testing - (ISTQB, CMSQ, etc.)
Successful History of managing multiple projects at one time
Managed teams/projects of > 80 headcount which includes matrixed staff
Successful history of implementations with multiple vendor integrators
Used multiple methodologies: Agile , Waterfall, RUP, RAD
Familiar with principles of Testing Centers of Excellence

QA Director Resume Examples & Samples

Will be responsible for overall Quality Assurance / System Validation Tests for 1350 OMS
Will lead a large team of 80+ people world wide
Will interface with 4LS, Customer Teams in case of field quality issues
Will drive the changes in Quality Process
Will drive the Quality Assurance/SVT strategy release on release
Will coordinate with the NE team and NSP team for joint testing

QA Director Resume Examples & Samples

Develop a culture of automated testing that accelerates software delivery with the goal of a continual deployment model
Champion the customer experience and ensure that we are collectively delivering a high-quality product
Lead the transition from Quality Assurance to Quality Engineering, where test engineers develop automated tests in lock-step with new feature development
Lead recruiting efforts to increase our focus on automation testing
Develop the engineers and managers on your team through coaching, mentoring, and performance management
Develop management systems and performance measurement dashboards to transparently track and report on performance
Deliver recommendations to drive short, medium and long-term performance operational improvements
Drive operational efficiency initiatives that improve profitability and customer satisfaction
Apply financial rigor and business acumen to all initiatives to help the management team arrive at decisions that maximize business performance
Maintain an appropriate balance across short-term and long-term planning and resource investment
The successful candidate will be an experienced operational leader with a track record of successfully managing quality controls and assurance for software that runs on-premise and in the cloud
S/he has to be someone who is excited and motivated by building efficient, large scale test automation systems that supports continuous integration
Technically astute, and up to date on all the relevant testing methodologies
Experience implementing a Quality strategy that leverages an automation-first test approach supports data-driven release decisions, and accelerates development while minimizing risk
The ideal candidate will be cool under pressure and an expert in crisis management who can quickly translate learning’s into operational improvements through driving root cause analysis and detailed remediation plans
Furthermore, s/he will be viewed as a trusted colleague and collaborator, and will be known for reaching out across organizations and functions to build support and get things done

Client Data Services Americas Risk & Control QA Director Resume Examples & Samples

Substantial and relevant PMO experience in a global banking environment
Exposure to Client Onboarding, KYC or similar regulatory projects is preferred
Numerate individual with a Finance or Business related degree
Ability to work under pressure to tight deadlines
Strong organisational and administrative skills
Client focused approach and ability to react quickly to changing demands

Associate QA Director, Great Britain Resume Examples & Samples

Serve as Regional or Global QA Liaison for assigned customers, therapeutic groups and/or functional areas
Support Quality Management in proposal reviews and reporting QA metrics
Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
Direct and / or participate in the scheduling, preparation for, conduct, reporting, and close out for all audits assigned. This may include, but is not limited to, internal, external, client and vendor audits
Participate in review and closure of corrective actions, as required. Act as a resource for information, consultation and training concerning applicable regulations, guidelines and quality issues to study teams, working groups, and task forces for assigned projects
Act as a resource to the department by providing guidance, interpretation, training and key input regarding operating procedures and processes
Facilitate the conduct of customer-initiated audits, mock regulatory inspections, and assists in regulatory facility inspections, as applicable. May host customer audits and works with responsible parties to prepare corrective action plans
Maintain working knowledge of current applicable regulatory regulations and guidelines and related auditing techniques
Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to management within specified regional timelines. Collect and report quality metrics as required to Quality Management
Assists in conducting training seminars on Quality issues and SOP development
Works with global counterparts to ensure global standardization within the departments
Strong knowledge of pharmaceutical research and development processes and regulatory environments
Strong interpersonal skills and the ability to positively influence and guide others
Possess applicable experience in conducting audits, writing audit reports and analyzing audits
Demonstrated ability to lead and manage multiple responsibilities
Identify functional constraints and identify solutions
Ability to coordinate timelines with internal customers and external vendors
Ability to manage multiple activities and timelines
Ability to articulate and define departmental needs and processes
Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech
Regular sitting for extended periods of time
Travel as required

Bicep Technology Horizontal QA Director Resume Examples & Samples

Governance and oversight of the BICEP wide Technology delivery for a particular set of Horizontals/Verticals (e.g. technology Horizontal or CSO/Data Management)
Pro-active identification and resolution of major programme calibration (i.e. scope), delivery risks and issues
Reporting, governance and stakeholder management
Consistent approach across all work streams
Creation, completion and management of the technology quality assurance framework for BICEP
Primary Duties
Engage with the CCO Centre of Excellence to understand objectives, processes and templates to follow with the aim of supporting their agenda and de-risking delivery plans
Drive calibration sessions for the area(s) in charge, focusing on
Scope
Approach, deliverables
Dependencies
Cross programmes dependencies
Identify inter and intra programmes dependencies and critical paths cross programmes
Manage active short – medium term assignments to understand and resolve critical program delivery issues of the moment
Develop comprehensive front to back reporting and pro-actively manage / escalate key Tech risks and issues as they emerge
Develop and maintain a forward looking “radar” on critical activities, and associated risks and issues for early management attention and resolution
Partner with Tech Risk & Control, Control Standard Owners and Tech Assurance teams
Create option papers to support senior management decision making when required
Monitor on an ongoing basis the evolution of key delivery success factors, critical paths and delivery risk
Create communication artefacts for senior management providing transparency on key delivery success factors, delivery risk
Maintain and execute technology quality assurance tracker that will enable to confirm activities are delivered in a timely and quality fashion
Programme management
Delivery lifecycle
Change