Senior Director, Quality – United States Operations (GxP, GCP, GMP, GDP Leadership)
Location: Plainsboro, New Jersey, United States
Function: Clinical Development – Clinical, Medical & Regulatory (CMR)
Company: Novo Nordisk
Travel Requirement: 20–30% overnight travel
Role Overview
Novo Nordisk is hiring a Senior Director, Quality – United States Operations to lead GxP compliance strategy and Quality Management Systems (QMS) oversight across U.S. Clinical, Medical, and Regulatory operations. This executive leadership role is responsible for Good Clinical Practice (GCP), Good Distribution Practice (GDP), and Good Manufacturing Practice (GMP) support across U.S. Quality functions.
The Senior Director serves as the Quality Responsible Person for U.S. Operations and acts as the primary contact for U.S. FDA GxP inspections, including GCP, Pharmacovigilance (PV), and medical device inspections. This position provides strategic direction, inspection readiness leadership, vendor oversight, and regulatory alignment across U.S. Operations while representing the U.S. organization in global quality governance forums.
This role is ideal for senior quality leaders with deep pharmaceutical GxP expertise, FDA inspection experience, and strong cross-functional leadership capability.
About the Clinical, Medical & Regulatory (CMR) Department
The CMR organization at Novo Nordisk integrates Clinical Development, Regulatory Affairs, Medical Affairs, and Quality functions to advance patient-centered innovation. The team works closely with the U.S. Food and Drug Administration (FDA), healthcare providers, and global R&D to ensure regulatory compliance, product safety, and quality excellence.
CMR is driven by a patient-first philosophy, supporting product development, regulatory strategy, pharmacovigilance compliance, and quality governance across the lifecycle.
Key Responsibilities
Strategic Quality Leadership
Lead GCP, GMP, and GDP compliance across U.S. Operations.
Serve as the Quality Responsible Person for U.S. Operations.
Provide strategic direction for U.S. Quality and contribute to global Quality leadership forums.
Represent U.S. Quality in Global Operations Quality Leadership Team meetings and R&D Quality committees.
Ensure U.S. regulatory insights inform enterprise-level Quality and R&D strategy.
FDA Inspection & Regulatory Oversight
Act as the primary point of contact for U.S. FDA GxP inspections (GCP, PV, Devices).
Partner with Regulatory Affairs leadership during health authority inspections.
Represent Novo Nordisk in global sponsor inspections by regulatory authorities.
Ensure inspection readiness across all applicable GxP domains.
Quality Management System (QMS) Governance
Lead implementation and oversight of an effective and compliant QMS aligned with global standards.
Direct development and maintenance of SOPs, Quality documentation, ISO standards, and regulatory records.
Oversee Quality Management Review (QMR) processes and Quality Assurance Program (QAP) reporting.
Drive continuous improvement initiatives and cultivate a strong Quality mindset across U.S. Operations.
Audit & Self-Inspection Leadership
Develop and execute the U.S. GxP audit strategy.
Oversee internal audits, vendor audits, and FDA inspections.
Lead the U.S. self-inspection program, including CAPA oversight and trend analysis.
Product & Operational Quality Oversight
Provide Quality support to U.S. manufacturing facilities, product warehouses, and supply chain operations to enable compliant product release.
Oversee patient safety outsourcing compliance, CRO oversight, and vendor governance.
People & Organizational Development
Lead and mentor the U.S. Quality organization.
Ensure all team members maintain Individual Development Plans aligned with business strategy.
Manage functional budgets, resource allocation, and productivity metrics.
Balance cross-functional stakeholder priorities and escalate risks when required.
Required Experience
Minimum 15 years of progressively responsible experience in Quality Assurance, GCP, GMP, GDP, or related GxP disciplines within the pharmaceutical, biotechnology, CRO, or healthcare industry.
At least 8 years of direct Quality leadership experience in a regulated pharmaceutical environment.
Minimum 5 years of supervisory or senior leadership experience managing Quality teams.
Demonstrated expertise in FDA inspections and global health authority interactions.
Proven experience leading enterprise-level Quality Management Systems.
Strong background in pharmacovigilance compliance and vendor oversight is preferred.
Experience representing organizations at senior international leadership forums is highly desirable.
Educational Qualifications
Bachelor’s degree required (Life Sciences, Pharmacy, Regulatory, or related field preferred).
Advanced degree (MS, PharmD, MBA, or equivalent) preferred.
Core Competencies
Expert-level understanding of GCP, GMP, GDP, and regulatory compliance frameworks.
Strong analytical, negotiation, and executive communication skills.
Experience managing cross-functional and global stakeholders.
Ability to lead high-performing teams in complex regulatory environments.
Advanced proficiency in Microsoft Office and project management tools.
About Novo Nordisk
Novo Nordisk is a global healthcare leader with more than a century of scientific innovation focused on defeating serious chronic diseases. With a strong presence in diabetes, obesity, and metabolic disease treatment, the company combines research excellence, regulatory leadership, and patient-centric values to improve health outcomes worldwide.
With over 63,000 employees globally, Novo Nordisk integrates innovation, compliance excellence, and sustainable growth to shape the future of healthcare.
Equal Opportunity Statement
Novo Nordisk is an equal opportunity employer committed to inclusive hiring and equal employment opportunity for all qualified applicants.
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