Senior QA Specialist, External Manufacturing, US
Bavarian Nordic
Summary
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.
Job description
Position Overview
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.
Key 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
In addition, you will contribute to a range of related QA activities:
- 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
Qualifications
- 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
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
- In-depth understanding of EU GMP Annex 1
- In-depth understanding of sterile fill-finish operations
- In-depth understanding of 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
Benefits
- Flexible work environment
- Professional development
Company overview
Bavarian Nordic is a global vaccine company headquartered in Copenhagen, Denmark, with over 30 years of experience in developing life-saving vaccines. Founded in 1994, the company has evolved from a small biotech startup into a fully integrated vaccine company focused on the research, development, manufacturing, and commercialization of innovative vaccines. Bavarian Nordic employs over 1,400 dedicated professionals across multiple international locations including Denmark, Germany, the United States, Canada, Switzerland, Italy, Spain, and the United Kingdom. The company is recognized as a global leader in smallpox and mpox vaccines, developed through its long-standing partnership with the U.S. Government to enhance public health preparedness. Their portfolio also includes vaccines for travelers and endemic diseases, with a strong focus on infectious diseases and biodefense. Bavarian Nordic operates as a pure-play vaccine company with a firm commitment to improving and saving lives through innovative immunization solutions, maintaining a diverse workforce bound together by their mission to protect lives every day.