Director – Product Quality
Location: Boulder, United States
Category: Quality
Company: Novo Nordisk
Employment Type: Full-Time
About the Department
Novo Nordisk’s Research & Development organization spans Lexington, Watertown, Cambridge, and Seattle. It covers the full R&D continuum—from early research to late-stage clinical development.
The R&D hubs combine:
Biotech speed and agility
Big pharma quality, resources, and stability
The focus is on advancing innovative science, strong collaborations, and developing impactful medicines that improve human health.
Position Summary
The Director – Product Quality oversees the CMC Quality Assurance (QA) organization for the site. This role:
Leads QA functions
Ensures compliance with regulatory and QMS requirements
Supports clinical product manufacturing and testing (including CMOs)
Drives site readiness for clinical API manufacturing
Aligns QA strategy with short-, medium-, and long-term business priorities
Reports to: Corporate Vice President
Key Responsibilities
1. Quality & Compliance Leadership
Serve as a key partner to site leadership for quality integration and site strategy.
Ensure compliance with global regulatory requirements and internal quality standards.
Participate in the Quality Leadership Team to define quality goals, objectives, and policies.
Ensure alignment of quality goals with site objectives (Novo Nordisk Way).
Provide expertise on GMP compliance and quality expectations.
2. Quality Management & Oversight
Oversee Quality Assurance functions supporting manufacturing and testing of clinical products.
Ensure robust Quality Management Systems (QMS) across the site.
Drive internal audits and oversee external inspections of CMOs.
Maintain strong communication and alignment with site and global stakeholders.
Support qualification and operational readiness for clinical API manufacturing.
3. People & Team Leadership
Direct, coach, and develop the site quality management team.
Lead training, development, talent recruitment, and performance management.
Oversee financial management, employee relations, and process improvements.
Ensure technical training and Quality Management competency across the site.
4. Communication & Collaboration
Maintain effective collaboration across site leadership, global partners, and stakeholders.
Provide quality input to ensure product safety and regulatory success.
Drive continuous process improvement initiatives and cross-functional alignment.
5. Other Responsibilities
Follow all safety and environmental requirements.
Perform additional tasks as assigned.
Physical Requirements
Ability to work in an open office environment with potential distractions.
Travel up to 10%, based on business needs.
People Development Requirements
Supervisory responsibilities include:
Ensuring all direct reports have Individual Development Plans (IDPs)
Conducting interim reviews aligned with business priorities
Managing learning, aspiration plans, and capability development
Communicating and enforcing Novo Nordisk policies and the Novo Nordisk Way
Qualifications
Education
Bachelor’s degree in science, engineering, business, or related field (required)
Master’s degree preferred
Experience
Minimum 10 years in pharmaceutical quality, API industry, manufacturing, or related area
Minimum 5 years managing managers
Strong knowledge of GMP regulations
Experience in parenteral or API systems preferred
Proven experience mentoring and developing teams
Skills
Excellent written and verbal communication
Strong presentation skills
Change management, organizational planning, and execution
Process improvement and problem-solving expertise
Ability to review and guide complex organizational plans
Compensation & Benefits
Base Salary Range
$181,670 – $317,920
(Based on experience, internal equity, and other factors)
Additional Compensation
Eligibility for company performance bonus
Long-term incentive compensation
Company vehicle (based on position level)
Benefits
Employees are eligible for:
Medical, dental, vision insurance
Life and disability insurance
401(k) with employer contributions
Flexible spending accounts
Tuition reimbursement
Employee assistance program
Voluntary benefits (legal, critical illness, pet insurance, etc.)
Paid sick time, flexible vacation, parental leave
Diversity & Inclusion Statement
Novo Nordisk is committed to an inclusive recruitment process and equal opportunity employment. All applicants will receive consideration without regard to race, ethnicity, gender, identity, sexual orientation, disability, veteran status, or other protected characteristics.
Accessibility
Applicants needing accommodations may contact:
📞 1-855-411-5290
(For accommodation requests only)
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