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Director - Product Quality

5-10 years
$181,670 – $317,920
10 Nov. 14, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)