New · posted Oct 15
Bavarian Nordic · Biotechnology
Senior QA Specialist, External Manufacturing
- Remote, US), East Coast preferred
- Remote
- Full-time
- Senior & Principal
Open until filled
The role
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.
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
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.
What you need
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
What you'll do
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
Pay
$120,000 – $155,000 a year
Employer providedProtecting 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
Join a passionate, mission-driven global biotech committed to protecting lives. At Bavarian Nordic, you’ll find a collaborative culture, flexible work environment, and opportunities for ongoing professional development and growth.
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.
For more information, visit www.bavarian-nordic.com
From the posting
About Bavarian Nordic
At Bavarian Nordic, we are dedicated to protecting lives and advancing global health through innovative vaccines. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. Our mission is simple: to improve quality of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and North America.
Equal opportunity, accessibility and legal noticesBavarian Nordic's statements, word for word
Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,000 | — | $155,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: Bavarian Nordic's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Bavarian Nordic's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Collaboration and leadership7
- Quality systems and risk4
- Investigations and CAPA3
- Validation and qualification3
- Documentation and SOPs2
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
Company hiring pulse
Bavarian Nordic on Regulatory Jobs
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- Open roles
- 2
- Distinct roles
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- Locations
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Senior QA Specialist, External Manufacturing at Bavarian Nordic
Open until filled. $120K–$155K a year, employer provided.