Sr. QA Specialist - Pharmaceutical Manufacturing
Novo Nordisk
August 09, 2026
On-site
West Lebanon, NH
Operations
The Position
- Work with the management team to set future quality direction and support implementation of site quality goals by bringing best practices from other Novo Nordisk sites.
- Review/approve manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site biologics produced.
- Provide QA signature authority for review of individual batch records, supporting test records, and other ancillary support records.
- Develop and coach QA colleagues; support manufacturing by being present on the manufacturing floor.
- Drive implementation of quality improvement projects and support cross-functional projects across the site.
Essential Functions
- Train, mentor, and develop QA colleagues.
- Identify training needs and deliver training materials/programs, including compliance and other QA topics.
- Serve as a GMP expert to evaluate and improve training program effectiveness.
- Partner with Manufacturing and Quality Control to resolve open issues from record reviews, internal audits, and deviations.
- Inform stakeholders on project goals and deliverables; consult/mentor across business operations.
- Review and assess deviations (evaluation, tracking, follow-up, reporting/trending).
- Review and approve validation documentation.
- Review and assess Corrective and Preventive Action (CAPA) reports.
Qualifications
- Bachelor’s degree in a scientific or life science field (required).
- Master’s degree (preferred).
- 10 years’ experience with a Bachelor’s degree (required); 8 years (preferred with Master’s); 6 years direct QA experience (preferred).
Skills/Abilities (Required/Preferred)
- Excellent written/verbal communication and negotiation skills in English (required).
- Strong planning/organization; flexible with changing priorities.
- Ability to exercise judgment within defined practices/policies.
- Ability to work on complex quality projects involving data evaluation.
- Ability to train/mentor junior team members in QA best practices.
- Extensive knowledge and proven experience with GMP API/pharmaceutical manufacturing.
- Good stakeholder management and collaboration.
Application Instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- Work with the management team to set future quality direction and support implementation of site quality goals by bringing best practices from other Novo Nordisk sites.
- Review/approve manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site biologics produced.
- Provide QA signature authority for review of individual batch records, supporting test records, and other ancillary support records.
- Develop and coach QA colleagues; support manufacturing by being present on the manufacturing floor.
- Drive implementation of quality improvement projects and support cross-functional projects across the site.
Essential Functions
- Train, mentor, and develop QA colleagues.
- Identify training needs and deliver training materials/programs, including compliance and other QA topics.
- Serve as a GMP expert to evaluate and improve training program effectiveness.
- Partner with Manufacturing and Quality Control to resolve open issues from record reviews, internal audits, and deviations.
- Inform stakeholders on project goals and deliverables; consult/mentor across business operations.
- Review and assess deviations (evaluation, tracking, follow-up, reporting/trending).
- Review and approve validation documentation.
- Review and assess Corrective and Preventive Action (CAPA) reports.
Qualifications
- Bachelor’s degree in a scientific or life science field (required).
- Master’s degree (preferred).
- 10 years’ experience with a Bachelor’s degree (required); 8 years (preferred with Master’s); 6 years direct QA experience (preferred).
Skills/Abilities (Required/Preferred)
- Excellent written/verbal communication and negotiation skills in English (required).
- Strong planning/organization; flexible with changing priorities.
- Ability to exercise judgment within defined practices/policies.
- Ability to work on complex quality projects involving data evaluation.
- Ability to train/mentor junior team members in QA best practices.
- Extensive knowledge and proven experience with GMP API/pharmaceutical manufacturing.
- Good stakeholder management and collaboration.
Application Instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).