Senior QA Lead - GMP Pharmaceutical Manufacturing

Novo Nordisk

West Lebanon (NH)

On-site

USD 110,000 - 140,000

Full time

3 days ago
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Job summary

Novo Nordisk A/S in West Lebanon, NH, is seeking a Sr. QA Specialist to lead QA activities onsite at our GMP manufacturing facility. The role emphasizes training and mentoring QA staff while ensuring compliance with GMP for biologics produced on site.

You will partner with Manufacturing and Quality Control to drive improvements, review batch records, and support cross-functional quality initiatives in a 24/7 production environment.

Qualifications

  • Bachelor’s degree in a scientific or life science field required.
  • Ten years of QA experience preferred with advanced degree.
  • Experience with GMP in API manufacturing.
  • Strong English communication and stakeholder management.
  • Ability to train and mentor junior QA staff.

Responsibilities

  • Train, mentor, and develop QA colleagues.
  • Identify training needs and deliver QA training.
  • Serve as GMP expert to evaluate training effectiveness.
  • Collaborate with Manufacturing and QC to resolve deviations.
  • Inform stakeholders about project goals and deliverables.
  • Mentor across operations and provide QA knowledge.
  • Review deviations, actions, and CAPA.
  • Review and approve validation documentation.
  • Review and assess corrective and preventive actions.
  • Uphold compliance with healthcare laws and Novo Nordisk Way.

Skills

English communication
Planning skills
Judgment & decision making
QA project analysis
Mentoring QA
GMP API knowledge
Stakeholder management

Education

Bachelor’s in Life Science
Master’s preferred

Job description

Novo Nordisk A/S in West Lebanon, NH, is seeking a Sr. QA Specialist to lead QA activities onsite at our GMP manufacturing facility. The role emphasizes training and mentoring QA staff while ensuring compliance with GMP for biologics produced on site.

You will partner with Manufacturing and Quality Control to drive improvements, review batch records, and support cross-functional quality initiatives in a 24/7 production environment.

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