Senior QA Specialist, External Manufacturing, US

Protecting our tomorrow

Job Title: Senior QA Specialist, External Manufacturing, US

Location: Remote, East Coast Preferred

Department: Quality Assurance

Reports To: Head of External QA & Global EHS

Salary Range: $120k - $155k

Position Overview

Do you want to be part of a collaborative and supportive QA team and play a key role in ensuring the quality and safety of vaccines supplied to patients worldwide?

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

• Bachelor9s 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

About the Team and Department

You will join a competent and supportive QA External Manufacturing team, reporting directly to the Head of QA for External Manufacturing. The team currently consists of eight colleagues. The group is a mix of experienced QA professionals with DBS UDP and FDP experience, fostering collaboration, knowledge sharing, and continuous development.

You will also become part of wider External department, comprising approximately 40 employees across sites in Kvistgaard, Denmark, and Munich, Germany. The department is characterized by close cross-site collaboration, a strong quality mindset, and a shared commitment to delivering safe and compliant products to patients.