Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted today

Senior QA Specialist, External Manufacturing, US

bavariannordic2 open roles

Where
Durham
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior QA Specialist, External Manufacturing, USbavariannordic · Durham

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on bavariannordic's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. bavariannordic postings stay open a median of 2 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.5%3 days
  3. 8.0%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted today

bavariannordic median: 2 days open

The posting

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

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.

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

  • 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

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.

Why Join Us

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.

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.

For more information, visit www.bavarian-nordic.com

#LI-MA1

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against bavariannordic's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on bavariannordic's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    bavariannordic's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.