Sr. QA Specialist - Pharmaceutical Manufacturing
Novo Nordisk
August 30, 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 on individual batch records, supporting test records, and other ancillary support records.
- Develop and coach QA colleagues and support manufacturing by being present on the manufacturing floor.
- Drive quality improvement projects and support cross-functional projects across the site.
Essential Functions
- Train, mentor, and develop QA colleagues.
- Identify training needs; deliver training materials/programs, including compliance and QA topics.
- Serve as GMP expert to evaluate and improve effectiveness of training programs.
- 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; provide specialized QA knowledge.
- Review/assess deviations (evaluation, tracking, follow-up, reporting/trending).
- Review and approve validation documentation.
- Review and assess corrective and preventive action (CAPA) reports.
- Perform duties compliantly and ethically; incorporate the Novo Nordisk Way and 10 Essentials.
Qualifications
- Bachelor’s Degree in a scientific or life science field (required); Master’s Degree preferred.
- Bachelor’s Degree plus 10 years of experience (required); Master’s plus 8 years preferred; 6 years direct QA experience preferred.
Required/Preferred Skills
- Excellent written/verbal communication and negotiating skills in English.
- Strong planning/organization; flexibility with changing priorities.
- Judgment within defined practices/policies; develop approach to solutions.
- Ability to work on complex Quality projects and evaluate data.
- Train/mentor junior team members in QA best practices.
- Extensive knowledge and proven experience with GMP API manufacturing in the pharmaceutical industry.
- Stakeholder management and collaboration skills.
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 on individual batch records, supporting test records, and other ancillary support records.
- Develop and coach QA colleagues and support manufacturing by being present on the manufacturing floor.
- Drive quality improvement projects and support cross-functional projects across the site.
Essential Functions
- Train, mentor, and develop QA colleagues.
- Identify training needs; deliver training materials/programs, including compliance and QA topics.
- Serve as GMP expert to evaluate and improve effectiveness of training programs.
- 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; provide specialized QA knowledge.
- Review/assess deviations (evaluation, tracking, follow-up, reporting/trending).
- Review and approve validation documentation.
- Review and assess corrective and preventive action (CAPA) reports.
- Perform duties compliantly and ethically; incorporate the Novo Nordisk Way and 10 Essentials.
Qualifications
- Bachelor’s Degree in a scientific or life science field (required); Master’s Degree preferred.
- Bachelor’s Degree plus 10 years of experience (required); Master’s plus 8 years preferred; 6 years direct QA experience preferred.
Required/Preferred Skills
- Excellent written/verbal communication and negotiating skills in English.
- Strong planning/organization; flexibility with changing priorities.
- Judgment within defined practices/policies; develop approach to solutions.
- Ability to work on complex Quality projects and evaluate data.
- Train/mentor junior team members in QA best practices.
- Extensive knowledge and proven experience with GMP API manufacturing in the pharmaceutical industry.
- Stakeholder management and collaboration skills.
Application instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).