What are the responsibilities and job description for the Site QC Head position at myGwork?
Key Responsibilities:
- Lead the Millburn Site QC function, about 40 associates, and manage resource allocation to ensure timelines and key milestones are met.
- Develop and strengthen the Quality Culture within the Quality Control organization.
- Ensure associates have development plans and identify opportunities for growth.
- Ensure quality systems for Quality Control, Environmental Monitoring, Stability, Analytical Science and Technology meet all applicable Health Authority regulations, guidelines, etc.
- Set and manage department objectives and performance.
- Develop and monitor KPIs across the organization, including, cycle time, reliability, RFT, etc.
- Identify and lead continuous improvement activities.
- Evaluate impact and anticipate implications of important emerging regulatory requirements, industry trends and external regulatory actions associated with Quality Control, Environmental Monitoring, Stability, Analytical Science and Technology.
- Collaborate through effective relationships and partnership with External Relations for the ongoing monitoring of emerging regulations, and where appropriate, participate in / collaborate with external working groups.
- Develop and implement strategies, processes and plans for inspection readiness.
- Represent Quality Control during internal and external inspections.
- Ensure adequate management of QC related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Controls.
- Procure site validation and qualification support, support site launches of manufacturing products.
- Ensure and maintain qualified status of lab equipment and methods for intended use in QC laboratories
Essential Requirements:
- BSc in Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related experience.
- Advanced Degree is preferred.
- 10 years' experience in Quality Control, Quality Assurance, Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries including prior experience with aseptic manufacturing.
- Experience in advanced therapies (Cell and Gene Therapy, Radioligand Therapy, etc.) is preferred.
- 5 years' experience leading and developing people.
- Experience developing high performing teams and talent management.
- Experience leading leaders is preferred.
- Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.
- Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
- In-depth knowledge of cGMP, applicable FDA Regulations (e.g., 21 CFR 4, 7, 11, 210, 211, 212), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc.
- Prior experience with Health Authority Audits / Inspections, including, front room and response to findings / observations.
- Must have an understanding of pharmaceutical industry trends and practices.
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
- Prior / advanced experience within microbiology, environmental monitoring, sterility assurance is preferred.
Desirable Requirements:
- Prior experience in a global, matrix organization
- Experience in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects
