Associate Director GMP/GDP Audit and Inspection Management
Proclinical is currently recruiting for an Associate Director of GMP/GDP Audit and Inspection Management for a leading biopharmaceutical company located in Boston, MA. AS the Associate Director, you will be responsible for internal audit program management, external supplier audit oversight and conduct, and providing inspection support related to our client's Cell and Gene Therapy (VCGT).
- Contributes to the overall strategy of the VCGT audit program, performance and effectiveness in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with applicable regulatory requirements (and guidances, etc.)
- Partners with QA leadership (e.g. QA Vendor Management ,Computer Systems QA, Operational Area QA) and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations (e.g. audit planning, review of audit outcomes, and corrective/preventive action development and implementation)
- Directs the development and maintenance of the integrated and risk-based VCGT Audit Plan and provides leadership in setting the direction to plan development, execution and adherence.
- Partners with stakeholders across functional areas in risk evaluation when determining the internal audit schedule and gains cross GxP and cross-program alignment for shared Quality Systems
- Engages in Preparation, Support and Follow-up activities for Inspection Readiness
- Supports due-diligence and business development activities, as requested
- May serve as GMP Quality Management System representative
- Participates in collaborative review of impacted SOP/WI
- Reviews and analyzes key Performance Indicator data and trends
- Analyzes risk and proposes remedial, corrective and /or preventive actions
- May participate in process improvement initiatives
Skills and Requirements:
- M.S. (or equivalent degree) and 7+ years of relevant work experience, or
- B.S. in a scientific or allied health field and 10+ years of experience in GMP QA including audit program development/maintenance and execution using risk frameworks in the regulatory compliance environment, or relevant comparable background.
- In-depth knowledge of regulations as they relate to cell and gene therapies with experience in auditing suppliers used in support of these programs.
- GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
- 21 CFR 600, 601, 610
- ATMP guidelines
- Global GMP regulations (US/EU etc.); 21 CFR Part 210/211, ICH guidelines and high level knowledge of 21 CFR Part 11 and International equivalents as necessary
- Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
- Risk management principles and process,
- Experience acting as Regulatory Inspection Host, Back-Room support and/or SME preferred
- Working knowledge of Aseptic practices and clean room design/operations
If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.