Title: Product Quality Lead
Location: Richmond, VA
Type: Full time, permanent
This role is responsible to plan, co-ordinate, and deliver activities of the Operational Quality Section within the North American region, to ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested, and can be dispositioned in full compliance with cGMP and regulatory requirements
- Provide final INDV review of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
- Assess temperature excursions during shipments according to the SOP. Raise deviations / provide Product Disposition Statements to establish and support the disposition of batches for local markets.
- Assist in providing direction in batch disposition of commercial product manufactured in the US into all authorized markets.
- Responsible for ensuring inspection readiness internally and at all key suppliers.
- Responsible for vendor assurance of all critical suppliers within the defined supply chain.
- Bachelor of Science degree, minimum, in a relevant scientific discipline.
- Proven track record, 5+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
- Direct experience in reviewing manufacturing & packaging batch records & analytical testing results.
- Microbiological experience a plus.
- Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.