Sr. Specialist, External Quality Operations

Title

Sr. Specialist, External Quality Operations

Our biotech client is seeking a Sr. Specialist in the Quality Assurance (QA) department reporting to the Sr. Director of External Quality Operations. This position will be responsible for ensuring quality of cGMP activities at external contract organizations (CxOs) for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal and external partners.

• Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products
• Oversee quality aspects for technology Transfer, commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external Cx Os
• Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable
• Liaise with external QA representatives and maintain external relationships
• Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations

• Life Sciences-based BSc or advanced degree with a minimum of 5 years’ QA experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment
• Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy
• Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations
• Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts
• Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity
• Experience working with CxOs and contract testing labs preferred
• Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

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