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Manager, External Manufacturing Quality, Pharma/GI::Raleigh

Raleigh, NC · Biotech/Pharmaceutical

The Manager, External Manufacturing Quality is responsible for providing quality oversight for our products manufactured and packaged by external contract manufacturing organizations (CMOs) and external Contract Packaging organizations (CPOs) for commercial distribution. This includes quality assurance for active pharmaceutical ingredient (API) and finished drug product (FDP). This position is responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of our products at CMOs partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements, and our Quality Management System. The Manager, External Manufacturing, Quality Assurance, will act as the lead quality point of contact for assigned projects. This position will be located in our Raleigh, NC office.

MINIMUM QUALIFICATIONS:
Bachelor’s degree in a science-related discipline, with fundamental focus in biology, chemistry, biochemistry, microbiology, cell biology, and/or biotechnology.
Experience: A minimum of 8 years of relevant and current work experience in pharmaceutical industry. Demonstrated experience with collaborative Contract Manufacturing and Contract Development and Packaging relationships. Demonstrated analytical skills to lead investigations of quality issues and justify CAPA with appropriate documentation. Demonstrated ability to broadly assess regulatory compliance audit findings and implement CAPA through negotiation. Experience with assessing validation requirements for manufacturing processes, facilities, and equipment. Demonstrated knowledge global regulations (i.e. ICH guidance, FDA/EMA GMP regulations and etc.) for manufacturing, packaging, and distributing active pharmaceutical ingredients and finished drug products. Experience evaluating quality systems specific to different manufacturing environments. Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority. Ability to expresses 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. Travel of up to 25% may be required.

PRINCIPAL RESPONSIBILITIES:
Supports our Operations related to commercial product distribution by:
• Approving and releasing commercial product: Batch record review and disposition for multiple products. Ensuring that product is safe, pure, and effective for distribution by direct review and inspection of the finished goods and documentation. Ensuring that all documentation for release is present, accurate and within established ranges and specifications. Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and /or contractual agreements.
• Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints. Ensuring that all incidents, complaints, and investigations are properly documented.
• Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action.
• Investigating and determining the need for field alerts or recalls of company products manufactured by CMOs.
• Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls. (e.g., master batch records, incidents and investigation reports)
• Perform on-site visits during manufacturing/packaging of our products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and our requirements.


Assures timely launch of new products by:
• Serving as the Quality lead for technical transfer activities at external manufacturing partners.
• Supporting manufacturing activities related to regulatory filings.
• Participation in and advisement of responses related to filing deficiencies.

  • Conducting formal risk assessments for CMOs and CPOs and ensuring implementation of identified controls/control plans. Continually assessing applicability of our Quality systems for managing CMO and CPO compliance and managing metrics for CMO and CPO Quality.
  • Representation of the department and  on cross-functional project teams and external business partner meetings.
  • Support regulatory authority inspections and leads inspection readiness efforts. 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 Quality Assurance input to strategic goals in form of schedules, quality plans, and budgets.
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