Remote Senior QA Lead, External Manufacturing

Bavarian Nordic A/S; North Carolina; Sur place; USD 120 000 - 155 000; Plein temps

Résumé du poste

Bavarian Nordic in the US is seeking a Senior QA Specialist to oversee external manufacturing partners in aseptic fill-finish operations, including vial filling, labeling and packaging, ensuring cGMP compliance and product quality for patients worldwide.

You will collaborate with CMOs, QPs and internal stakeholders to drive deviations CAPAs, audits, and continuous improvement, while ensuring regulatory requirements (FDA, EU GMP) are met and quality metrics are monitored.

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

Aseptic processing

CMOs/CDMOs oversight

FDA cGMP compliance

EU GMP Annex 1

Formation

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related discipline

Description du poste

Bavarian Nordic in the US is seeking a Senior QA Specialist to oversee external manufacturing partners in aseptic fill-finish operations, including vial filling, labeling and packaging, ensuring cGMP compliance and product quality for patients worldwide.

You will collaborate with CMOs, QPs and internal stakeholders to drive deviations CAPAs, audits, and continuous improvement, while ensuring regulatory requirements (FDA, EU GMP) are met and quality metrics are monitored.