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 also 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

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related discipline
10+ years of Quality Assurance experience within 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

QA Specialist – External Manufacturing

Key skills