Quality Senior Manager Job Description

Quality Senior Manager Job Description

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Quality senior manager provides an accurate, independent GMP/GDP/GxP assessment of CHC third parties for compliance with Corporate Quality Policy / requirements and applicable regulations through audit.

Quality Senior Manager Duties & Responsibilities

To write an effective quality senior manager job description, begin by listing detailed duties, responsibilities and expectations. We have included quality senior manager job description templates that you can modify and use.

Sample responsibilities for this position include:

Be responsible for establishing new method and balancing standard of quality management
The quality department
Propose improvements to current workflows to increase product quality metrics
Owns the data and analytics on product transit damages, define root cause & corrective actions working with manufacturing, design and supply chain functions
Owns governance & review process to drive actions
Leads continuous improvement of North America field & supply chain requirements (with the system architects) and lab test procedure (with the lab leaders) based on the learns from the field
Collaborate with platform package engineering to insert field / supply chain requirements into design guide
Development of business case to justify packaging changes along with category Product Quality Leaders
Major tasks in this role include program/project management
As a subject matter expert in packaging, this position will also be required to support daily business transactions to resolve packaging deficiencies or supplier quality issues

Quality Senior Manager Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Senior Manager

List any licenses or certifications required by the position: ISO, 9001, ASQ, API, PMP, HACCP, ITIL, NRA, NAVFAC, USACE

Education for Quality Senior Manager

Typically a job would require a certain level of education.

Employers hiring for the quality senior manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Education, Business, Management, Chemistry, Computer Science, Manufacturing, Healthcare

Skills for Quality Senior Manager

Desired skills for quality senior manager include:

International GMP and GDP regulations and subsequent applications to pharmaceutical drug product manufacturing
Animal testing
Application of phase appropriate
GSP
GXP and general quality compliance
Modality specific unit operations
Modality specific unit operations with the ability to influence and implement quality strategy
Quality and risk management principles and tools
Quality regulation requirements covering GLP
Risk-based quality principles

Desired experience for quality senior manager includes:

Manages escalations appropriately, ensuring risk related concerns are thoroughly understood and communicated to the appropriate stakeholders
The successful candidate will have extensive previous experience in Enterprise Technology Vendor Management, IT Governance, Risk and Compliance Oversight
Previous experience in an Architectural role, or technology lead, audit compliancy quality compliancy role
Technology Background, tech savvy
Demonstrates knowledge of Key Risk Indicators, and Risk Assessments
Exposure to multiple business units in BMO’s environment to understand the linkages and dependencies, solid knowledge of a specific area of BMO business

Quality Senior Manager Examples

1

Quality Senior Manager Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality senior manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior manager
  • Responsible for planning managing and conducting internal and external audits
  • Act as a central point of control for the resolution of internal and external audit findings while ensuring audit reports are issued in a timely manner
  • Collaborates with senior management to identify, evaluate, and recommend solutions to issues identified during performance of audits
  • Plans and conducts domestic inspections
  • Participates in the planning and conducting process of international inspections
  • Develops meaningful metrics and trends in order to implement process improvements of Quality Management System
  • Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures
  • Evaluates corrective and preventative action responses to audit findings for adequacy and timeliness and manage the closeout of all corrective and preventative actions
  • Provides audit related metrics to Senior Management
  • May provide ongoing feedback, development and performance reviews of staff
Qualifications for quality senior manager
  • Must be able to interpret and apply GCP regulations and guidances, including 21CFR part 11 requirements
  • Maintains professional expertise and knowledge of local and international regulations related to Quality and GCP
  • Strong knowledge of and ability to navigate Health Authority Websites
  • Prior hands-on experience with electronic data capture systems preferred
  • Ability to participate on interdepartmental teams
  • Ability to interact effectively with all levels of associates both internally and externally, including investigators and study site personnel
2

Quality Senior Manager Job Description

Job Description Example
Our company is looking for a quality senior manager. 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 quality senior manager
  • Leverage these relationships to identify customer challenges, needs and be able to influence customer architectures and roadmaps in favor of Xilinx
  • Participate in technical discussions and in the creation of new ideas for highest quality requirements for automotive autonomous vehicle applications
  • Identify and characterize, through technical benchmark analysis, specific Xilinx All Programmable value propositions that can positively differentiate Xilinx products & solutions from other
  • Monitor and manage progress at partners where automotive solutions funding is invested to subsidize development toward automotive OEM and Tier 1 customer’s needs and quality goals
  • Ensure that a robust and effective QMS process is established and implemented
  • Identify risks on technical feasibility and supply, timing and resources constraints and seek a remediation plan for identified risks and escalate any analytical technical and/or supply issues to the relevant body (project team, TDB, performance tower…)
  • Coordinate the alignment of QC labs deliverables link to testing of lifecycle product improvement projects in line with Global supply chain objectives in terms of quality, time and cost
  • Must be able to stand, sit, walk throughout the work day
  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies
  • Develop a strong quality team to improve customer satisfaction and quality objectives
Qualifications for quality senior manager
  • Ability to interact effectively with all levels of associates both internally and externally
  • Minimum 5 years’ experience within the Pharmaceutical/Biologics industry
  • Production/manufacturing experience advantageous
  • 10+ years in depth knowledge of quality systems
  • Required Other For FL/IL/MO/CA current unrestricted RN License
  • You will have also strong communication skills and ability to achieve results working with a variety of parties
3

Quality Senior Manager Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality senior manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior manager
  • Lead a core team comprising of the following functions including
  • Oversee the approval of objectives, policies, and programs to support the CCS Business Unit Quality Strategy
  • Ensure that the requirements and needs of the customer are clearly understood and defined
  • Develop and maintain effective Quality information systems that communicate key Quality related information and performance
  • Ensure all product-related Deviations are initiated, investigated and resolved
  • Develop and maintain appropriate Standard Operating Procedures in cooperation with Manufacturing
  • Provides advice and counsel to Purchasing in connection with the selection of vendors and purchase of materials
  • Develop and maintain appropriate safety programs for laboratory operations
  • Quality calibration/support for plant/lab measuring devices
  • Create and maintain a positive environment for all employees free of intimidation and harassment
Qualifications for quality senior manager
  • Ability to interact effectively with executives and other major (internal) customers
  • Minimum of 5-7 years’ experience in the pharmaceutical industry in clinical operations roles
  • Good knowledge of international GCP guidelines
  • Experience in successfully taking companies through required quality management certification processes and audits (AS9100, Regulatory, Customer ..)
  • Relevant Technical Bachelor’s Degree, Master’s Degree Preferred
  • 10 year minimum experience working directly with Automotive OEM or Tier 1 programs and managing large projects
4

Quality Senior Manager Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality senior manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior manager
  • Lead team with a strategic focus that includes needs of all EES sites
  • Perform system champion or deputy duties as assigned
  • Act as liaison to all EES sites & Suppliers ensuring that consistency exists between those sites, suppliers & corporate
  • Manage transition of all acquisitions & new suppliers into EES systems
  • Act as primary interface regarding supplier & EES documentation issues in all audits, including internal, GMP & ISO
  • Assure that EES suppliers have strong, capable quality systems & are in compliance with government & corporate regulations
  • Provide leadership to suppliers’ quality systems regarding strategic & tactical direction
  • Manage Production Quality workflows including Incoming / First Article, In-Process and Final Quality Inspection
  • Provide regular reports to management on Organization Quality and the performance of the EHSQ systems
  • Formulate and drive manufacturing quality excellence programs designed to assure maintenance of the Company’s competitive position and profitability of its manufacturing operations
Qualifications for quality senior manager
  • Lead and Implement business process management system for new clients
  • Drive and Track Quality DNA - training, testing & certification, Lead any other analytics
  • And productivity initiatives that come up
  • Coaching and Mentoring Process Owners and Team Members in DMAIC and Lean
  • Bachelor’s Degree in mechanical, mechanical engineering technology, biomedical engineering or other applicable technical degree from an accredited college or university
  • 7 years of related experience in the medical device industry
5

Quality Senior Manager Job Description

Job Description Example
Our innovative and growing company is looking for a quality senior manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior manager
  • May conduct vendor evaluation audits to determine qualifications
  • May also conduct training on quality assurance systems
  • Regular contact with internal customers (DCMA, on-site customer reps) and external customers
  • Regular contact with suppliers and subcontractors
  • Define quality parameters for our private label product portfolio
  • Develop monitor and review internal process (SOPs)
  • Responsible for applicable systems related to plant customer issues such as corrective action requests, supplier corrective action requests, nonconforming material reports
  • Serves as a quality technical resource to other functional areas
  • May coach and mentor less experienced quality engineers
  • Partner with Director, Data Analytics and the management team to create and execute on a robust strategy that integrates quality into all aspects of the claims experience
Qualifications for quality senior manager
  • Expert knowledge of health authorities requirements (GMP regulations e
  • Have a hands-on style and a willingness to perform a range of detail-level work, a doer rather than an administrator
  • Demonstrated leadership and facilitation skills in a matrix environment and ability to motivate all levels of the organization
  • BA or BS degree in a scientific discipline
  • Able to work independently on QA projects and initiatives with minimum supervision
  • Must be goal-oriented, quality-conscientious, and customer-focused

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