Senior QA Lead: GMP Compliance & Training

Biopharma Careers; West Lebanon (IN); On-site; USD 140,000 - 180,000; Full time

Job summary

Novo Nordisk in West Lebanon, NH seeks an experienced QA leader to set future quality direction and drive site-wide quality goals. You will review and approve manufacturing and support documentation to ensure GMP compliance, provide training and coaching to QA colleagues, and collaborate with Manufacturing and QC on deviations, CAPA and validation activities.

This role emphasizes cross-functional leadership, continuous improvement projects, and adherence to healthcare laws and Novo Nordisk

Qualifications

• Bachelor’s degree in a scientific or life science field.
• Ten years of QA experience with GMP preferred; Master’s degree with eight+ years is advantageous.
• Strong written and verbal English communication skills.
• Experience training QA staff and mentoring junior team members.
• Extensive GMP API manufacturing knowledge and hands-on QA leadership experience.

Responsibilities

• Train and develop QA colleagues.
• Identify training needs and deliver programs.
• Serve as GMP expert for evaluating training effectiveness.
• Collaborate with Manufacturing and QC to resolve issues.
• Inform stakeholders about project goals and deliverables.
• Mentor across business operations and provide specialized QA knowledge.
• Review Deviations, including tracking, follow-up, and trending.
• Review and approve Validation Documentation.
• Review and assess CAPA and corrective actions.
• Perform duties in compliance with healthcare laws and Novo Nordisk standards.

Skills

Communication

Planning & Organization

GMP Knowledge

Mentoring

QA Leadership

Stakeholder Management

Problem Solving

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

Novo Nordisk in West Lebanon, NH seeks an experienced QA leader to set future quality direction and drive site-wide quality goals. You will review and approve manufacturing and support documentation to ensure GMP compliance, provide training and coaching to QA colleagues, and collaborate with Manufacturing and QC on deviations, CAPA and validation activities.

This role emphasizes cross-functional leadership, continuous improvement projects, and adherence to healthcare laws and Novo Nordisk