Senior QA Specialist, External Manufacturing, US
About The Position
At Bavarian Nordic, our vaccines make a real difference. We are seeking an experienced Senior QA Specialist to support in the ongoing oversight of a Contract Manufacturing Organization (CMO) operating under aseptic manufacturing conditions. This role is critical to ensuring compliance, product quality, and operational excellence across sterile fill-finish operations, including vial filling, labeling, and packaging activities. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners. As our new QA Specialist, you will take on a broad and impactful role, working directly with our affiliated CMOs and closely with stakeholders across the organization to ensure high quality standards within External Manufacturing production.
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related discipline
- 10+ years of Quality Assurance experience in pharmaceutical or biotech manufacturing
- 5+ years of strong experience with aseptic processing and sterile manufacturing environments is required
- Demonstrated experience overseeing CMOs/CDMOs is a must
- In-depth understanding of: FDA cGMP regulations, EU GMP Annex 1, Sterile fill-finish operations, Validation and contamination control strategies
- Experience reviewing batch documentation and managing deviations/CAPAs.
- Excellent communication, organizational, and stakeholder management skills.
- Ability to travel periodically to manufacturing sites within the US or internationally as needed.
Responsibilities
- Ensuring CMOs maintain the highest levels of Quality standards conforming to cGMP and in conjunction with BN QAA
- Support the Bavarian Nordic QPs to enable the release of the highest quality vaccines
- Managing and resolving complex quality-related issues relating to aseptic operations including vial filling and labelling and secondary packing operations
- Promoting a strong quality culture and driving continuous improvement initiatives across areas
- Representing QA External Manufacturing in global and cross-organizational forums within Bavarian Nordic
- Review and approve GMP documentation including: Batch records, Deviations, CAPAs, Change controls, Validation protocols and reports
- Ensure compliance with FDA, EU GMP, ICH, and applicable US regulatory requirements
- Participate in risk assessments and investigations related to sterile manufacturing operations
- Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory Affairs, and Technical Operations teams
- Support technology transfers and process validation activities at external manufacturing sites
- Lead or participate in internal and external GMP audits
- Monitor quality metrics and drive continuous improvement initiatives with manufacturing partners
- Serve as the primary QA liaison between the client and the CMO
Benefits
- flexible work environment
- opportunities for ongoing professional development and growth
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What This Job Offers
Job Type
Full-time
Career Level
Senior
