The Director, Quality Assurance (QA) is responsible for developing and managing all aspects of the Quality Assurance program. This includes ensuring the appropriate level of quality assurance for commercial activities. The Director, QA, will implement design, develop, implement, and manage cGMP training, document control, change control and all other aspects of the Quality Management System. The Director, QA will also support the VP, Quality in providing input on strategic direction for the QA program and best practices for quality initiatives.
Minimum Bachelor’s degree in a biologics-related discipline, with fundamental focus in biology, chemistry, biochemistry, microbiology, cell biology, and/or biotechnology.
A minimum of 8 years of relevant and current work experience in the pharmaceutical industry in Quality Assurance.
Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority.
Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing quality systems in a regulated environment.
Ability to express self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; adjust style, language and/or terminology appropriate for the audience.
Proven track record of designing, developing, implementing, and overseeing cGXP Quality Systems in the pharmaceutical industry. (21 CFR 210, 211, 600, 820). Demonstrated understanding of product lifecycle requirements as applied from product development through continuing process verification (ICH Q7, 8, 9, 10, 11, and 12 as adopted by international competent authorities).
Expertise in application of Quality Risk Management principles to address design/development programs, technology transfer activities, change management, process validation, and continuing process verification activities.
Demonstrated experience with collaborative Contract Manufacturing and Contract Development and Packaging relationships. Previous small team management and familiarity with current organizational leadership programs.
Demonstrated understanding of applied scientific fundamentals associated with biopharmaceutical development and production.
Experience working with Quality Control personnel. Strong understanding of method validation, reviewing and approving analytical data.
Demonstrated understanding of commercial product regulated labeling.
20-30% travel associated with this role.
This role will be a Quality leader within the Quality organization and will need to educate other key leaders of Quality matters when required. He/she will identify and present risks as well as mitigating strategies so that consensus can be reached and pragmatic, compliant operating decisions can be made.
Support third-party audits and regulatory inspections, including preparing Subject Matter Experts, managing inspection schedules, maintaining control of documents and records, representing Quality with inspection teams, and managing closure of commitments as required in response to observations and other findings.
This position is responsible for the hiring, management and training of staff including resource utilization, definition of roles, career development and performance management while managing Quality activities in accordance with available budget, and resources.
Provide expertise and guidance in interpreting and implementing governmental and agency guidelines to assure compliance.
Provide Quality Assurance input to strategic goals in form of schedules, quality plans, and budgets. Write, review, approve, and maintain Standard Operating Procedures. Responsible for deviations, product complaint investigations, and GxP archives.
Conduct data analysis, ensure proper GMP documentation, and conduct peer review of data. Quality Systems, including approval and archiving of Standard Operating Procedures and GMP-controlled documents.
Audit and Supplier Quality, including quality agreements, preapproval inspection (PAI) readiness, manufacturing oversight, product complaint investigation, GMP training, internal and supplier audits, quality metrics and management reviews.
Solid understanding of FDA and EMA regulations.
Support regulatory authority inspections and leads inspection readiness efforts. Ensures that quality system metrics and trends as well as compliance issues and their resolution are tracked and presented to management with executive responsibility on a timely basis.