QA Manager: GMP Compliance & Continuous Improvement

Novo Nordisk A/S; Bloomington (IN); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Leading pay

Annual bonus

14 paid holidays

Health Insurance from day one

8% 401K company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee referral awards

Job summary

Novo Nordisk’s Bloomington, Indiana facility is seeking a Manager, QA to ensure FDA and other regulatory compliance, maintain quality systems, and lead QA operations. The role encompasses audits, documentation control, training, and cross-functional collaboration to deliver high-quality drug products.

The position requires a Bachelor’s in a related field (or equivalent with experience) and several years in cGMP/QA environments, with 1–3 years of management experience.

Qualifications

• Bachelor’s degree in a related field is required with minimum 4 years of relevant experience.
• Alternative: Associate’s degree with 6 years of relevant experience.
• Alternative: High School diploma with 8 years of relevant experience.

Responsibilities

• Oversee daily QA operations and ensure adherence to quality standards and timelines.
• Manage resources within the QA function and coordinate with stakeholders.
• Ensure training plans are executed and up to date; develop KPI reports.
• Lead cross-functional teams to implement process and system improvements.
• Review data, reports, deviations, and approve protocols and procedures.
• Coach and develop direct reports and manage performance reviews.

Skills

Quality Assurance

Leadership

Analytical skills

Communication

Organizational skills

Coaching

Problem solving

Education

Bachelor's degree in related field

Associate's degree in related field

High School diploma or equivalent

Job description

Novo Nordisk’s Bloomington, Indiana facility is seeking a Manager, QA to ensure FDA and other regulatory compliance, maintain quality systems, and lead QA operations. The role encompasses audits, documentation control, training, and cross-functional collaboration to deliver high-quality drug products.

The position requires a Bachelor’s in a related field (or equivalent with experience) and several years in cGMP/QA environments, with 1–3 years of management experience.