Director, Quality Assurance Job Description
Director, quality assurance
provides oversight of regulatory/standards requirements for areas such as Food and Drug Administration (FDA) regulations for finished drugs.
Director, Quality Assurance Duties & Responsibilities
To write an effective director, quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included director, quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating and managing performance
Contributes to the periodic reports for management review on the status of compliance, and quality standards of all facilities, processes, procedures and practices
Provides guidance, support and training to Ironwood personnel and external collaborators on interpretation of GCP regulations, guidelines, corporate standards and policies
Responsible for driving the adoption of best in class, large scale quality disciplines within our Financial Services systems (Asset Management, Retirement, Brokerage, and Business Process Management)
Supporting the Vice President of Professional Practices & Quality Assurance in managing and maintaining all aspects of QA Reviews
Overseeing the tracking, monitoring, and end-to-end management of corrective action plans associated with QA reviews
Supporting internal and external assessments of the Internal Audit function, including facilitating pre-planning and readiness reviews
Identifying improvement opportunities and best practices based on results of quality assurance reviews
Partnering with Audit Methodology and Professional Development team to design and deliver audit-related training program components to diverse groups of auditors with varying levels of experience based on QA results
Managing external benchmarking activities and maintain awareness of current, best-in-class internal audit practices
Director, Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Quality Assurance
List any licenses or certifications required by the position: ISO, ASQ, CLIA, HACCP, PCQI, GMO, AS9100, 9001, ITIL, SQF
Education for Director, Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the director, quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Technical, Education, Business, Management, Computer Science, Chemistry, Manufacturing, Biology
Skills for Director, Quality Assurance
Desired skills for director, quality assurance include:
Business
Member service components and operational processes
Standards
Regulatory laws and best practices
Applicable regulations
Drug development process
FDA
FDA regulations
Concepts
Current and emerging global guidelines and regulations
Desired experience for director, quality assurance includes:
Providing support to for special projects lead by the greater Professional Practices team or the Quality Assurance team, as needed
Leading auditors, as needed, to perform effective and targeted quality assurance reviews
Effectively teaching, coaching, and developing team members, as appropriate
A strong Leader with experience managing a multi-sourced organization is a must
Strong knowledge of the software development lifecycle (software development methodologies, metrics and procedures)
Experience in designing and implementing QA and testing methodologies and practices preferred
Director, Quality Assurance Examples
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Director, Quality Assurance Job Description
Job Description Example
Our company is looking for a director, quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, quality assurance
- Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies
- Responsible for maintaining internal regulatory submissions and licenses
- Manages exempt and non-exempt Quality and Regulatory staff
- Interfaces with both internal groups (such as Design, Process R&D, Applications and Marketing), external customers for product quality issues
- Serves as the key technical contact to communicate product quality issues identified internally from customers with OmniVision’s supply chain (foundry fab, packaging and final test) and drive improvement across the supply chain
- Coordinate, prepare, and manage CMC (Quality) documentation for submissions and subsequent variations/supplements
- Oversee and be ultimately responsible for quality assurance program
- Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function
- Supervise/Manage QA functions for scheduled/unscheduled maintenance IAW with the CNAFINST 4790.2 Series, Contractor GOP’s and applicable T/M/S Maintenance Instruction Manual (MIMs)/Tech Pubs
- Perform CNAFINST 4790.2 Series SOP monitoring, quarterly audits, trend analysis
Qualifications for director, quality assurance
- Strong experience with manual testing, testing tools
- Mercury Quality Center, Loadrunner, or other similar tools - Basic understanding including navigation between functional areas within the tool
- BS or MS in Computer Science or related discipline or equivalent work experience preferred
- PC skills, including MS Word, Excel, Lotus Notes-with desired experience in implementing new processes, demonstrated team leadership skills and collaborations skills
- Significant knowledge and insight into qualification and validation activities and the ability to partner effectively with engineering and operations teams in completing these tasks
- Oversee the continuous improvement of Quality Management Systems at sites around the world, including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, validation, and manufacturing area support
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Director, Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking for a director, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, quality assurance
- Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions)
- Interfaces with internal QA functions to ensure appropriate quality oversight of the program/product
- Provides day-to-day support to applicable QA functional line
- Maintains an independent and non-biased role in working with customer area
- Provides training and mentorship to less experience members of QA staff
- Possesses high level of expertise within applicable TA and continually enhances knowledge
- Is responsible for ensuring delivery of high quality and timely information to appropriate levels of management
- Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues
- Engages in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues
- Requires up to 30% time for conducting audits (including travel) and attending QA meetings
Qualifications for director, quality assurance
- Utilizing a suite of testing tools that includes Quality Center, Quick Test Pro
- Bachelor's Degree in Scientific/Technical field
- A minimum of 8-10 years of management experience in a GMP or similarly regulated environment
- Ten (10) years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function
- Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint) clinical data management programs
- Possess knowledge of relevant Quality measurement approaches and systems
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Director, Quality Assurance Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, quality assurance
- Engages the VP of Finance and CFO and other “business owners”, as applicable, of issues, trends, and changes impacting their areas of responsibility
- Plan for and oversee all internal and external audits across clinical research program and manufacturing facilities
- Plan for and oversee all internal and external monitoring across the clinical research program and manufacturing facilities to ensure compliance with institutional, federal and other applicable clinical research regulations
- Ensure top quality research is performed by tracking essential metrics, evaluating risks, crafting trend reports and implementing policies and procedures
- Act as a primary liaison with clinical department leadership to efficiently and effectively meet the clinical research goals
- Oversee complete internal and external communications to all stakeholders
- Engage as needed with local, State and Federal Regulators customers
- Reports to management on quality issues, trends and losses
- Participates in internal and external quality audits
- Develop and Direct Quality Assurance program ensuring compliance with State and Federal mandates directing quality performance and conducting continuous improvement activities
Qualifications for director, quality assurance
- Experience with data analysis, preparation of technical reports, process validation, statistical process control, and statistical sampling plans is required
- An experienced practitioner in tools like SPC, 8D, PDCA, RCA, Six Sigma, and Lean
- Experience in a startup environment global public companies
- Experience in Solar
- Ability to influence others and able build a company culture of quality
- GCP experience a plus
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Director, Quality Assurance Job Description
Job Description Example
Our company is looking to fill the role of director, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, quality assurance
- Understand/clarify Business Partner’s needs and engage in regular feedback on how the department is meeting those needs focusing on quality of the
- Monitor all operations and related metrics for conformance with internal, external, contract performance, and quality standards
- Aggregate and analyze quality data and suggest methods for improving product and service quality, design and/or business processes
- Define quality control standards and test
- Responsible for reviewing work-papers and issue summary reports to ensure they meet quality and timeliness standards
- Leads a group of QA staff to ensure that end to end solution meets customer requirements in agile environment
- Implements efficiencies in the testing life cycle
- Develops and implements key performance and risk indicators to continuously drive improvements in both testing execution process and quality of product
- Participate in or lead teams for special projects as assigned
- Direct the team to ensure all requirements of the Product Development Process (PDP) are met, including product/process, regulatory, and Quality System compliance
Qualifications for director, quality assurance
- Word, Excel, Project and PowerPoint or equivalent required
- Experience with electronic data systems preferred
- Ability to multi-task as needed in a start-up environment
- Solid understanding and experience in programming languages (Java, C#, Python etc)
- Familiarity with signal detection systems is a plus
- Bachelor's degree and/or insurance related designations preferred
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Director, Quality Assurance Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, quality assurance. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, quality assurance
- Establish, maintain and enforce division and group policies and procedures necessary for compliance with current FDA medical device regulations, Quality System Regulation (21 CFR Part 820)
- Participate in inspections/audits by the notified body or other regulatory agencies to include FDA by producing requested documents or answering any inquiries for information
- Prepare all correspondence to FDA
- Assist staff in the preparation and submission of all premarket notifications [510(k)] to the FDA
- Provide guidance and strategy to M- BCs and interact with FDA as necessary to develop regulatory and device strategy, including all necessary testing and documentation that may be required for device clearance
- Establish and maintain a strategy for automating test cases across multiple projects and products
- Partner with development and product teams to understand product architecture and project timelines
- Work with operations team to build system and process expertise
- Establish manual and automated testing best practices and research and recommend tools, applications and frameworks to help QA achieve its goals and objectives
- Directly supervises subordinate managers and supervisors
Qualifications for director, quality assurance
- Manage and oversee all local GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, and data/IT audits (AIM)
- Master’s Degree in Science (Chemistry, Microbiology or Biology preferred)
- Solid understanding of US and international PV regulations and guidelines (CFR, ICH...) their practical implications
- Experience working collaboratively with senior level management
- Experience working with DOT, government regulatory agencies
- Strong analytical, research, and forecasting skills