Director, United States Operations Quality Audits & Inspections

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

Lead independent, risk-based quality audits and inspection readiness across the approved USO Quality (USOQ) domain. Develop and execute the audit and self-inspection strategy to assess compliance, control effectiveness and risks to patient safety, product quality and data integrity across applicable current GxPs [Good Clinical (GCP), Pharmacovigilance (GPV), Distribution (GDP) and Manufacturing (GMP)] practices]. Maintain an objective view of business and Quality activities, including outsourced activities within scope. Lead sustained audit and inspection readiness and act as the designated local health authority inspection point of contact and inspection lead for the USOQ domain, coordinating with Regulatory Affairs, Global Quality, Patient Safety and accountable business leaders. Ensure readiness gaps and regulatory commitments are visible, owned, and escalated. Provide independent assurance over external-party quality controls through risk-based audits & remediation plans.

Relationships

Position reports to the Head of USO Quality. The sponsor approves the audit charter and risk-based plan, reviews resource adequacy, receives unfiltered findings and has formal input into the Director’s appointment, removal and performance assessment. The Director has direct access to the sponsor to escalate interference, disputed findings, scope restrictions and unresolved material risks. Interface with multiple Novo accountable business leaders, Regulatory Affairs, Legal, Safety, global Quality Audit and Global Clinical Compliance. External relationships include health authorities, clinical trial sites, external auditors and relevant vendors and partners. Coordinate USOQ inspection communications through approved authority channels without displacing global, legal-entity, Regulatory or Safety accountabilities. This role manages the independent audit and inspection department, with multiple experienced quality representatives assigned to diverse quality functions and includes auditor competence, inspection leadership, workload, budget and continuity.

Essential Functions

• Direct Independent Audits and Self-Inspection Program & Staff
• Maintain the USOQ audit charter, audit universe and risk-based audit and self-inspection strategy. Define scope, frequency, methods, auditor qualifications and escalation criteria across business functions, Quality verticals and relevant external parties. Secure approval of audit plans and material changes, ensure authorized access to personnel, sites, systems and records and align with global audit programs to prevent duplication and coverage gaps
• Lead the annual audit & self-inspection program, including routine, risk-triggered and for-cause reviews. Assign qualified, independent auditors; oversee evidence-based assessments of control design, effectiveness, data integrity and external-party controls. Ensure consistent finding classification, clear communication and timely reporting. Manage budget and staffing, document plan deviations and escalate material coverage or resource gaps
• Inspection Readiness and Health Authority Leadership
• Lead inspection readiness with business and Quality leaders through assessments, mock inspections, playbooks, document-retrieval exercises, SME preparation and trained deputies. Define inspection-team roles, front- and back-room responsibilities, request tracking and escalation. Coordinate USOQ administrative support while leading readiness coordination and independent challenge. Business and process owners retain responsibility for compliant operations, source records and readiness evidence
• Serve as the designated local health authority inspection contact and lead within approved USOQ scope, including FDA and other formally assigned authorities. Coordinate inspection logistics, meetings, interviews, requests and communications with Regulatory Affairs, global functions and accountable SMEs. Lead observation triage, response coordination and commitment tracking. Secure authorized approvals for submissions, commitments and risk acceptance; retain established company signatory, Regulatory and Safety reporting authorities
• Finding Ownership and Remediation Oversight
• Ensure all audit, self-inspection and inspection findings have accountable business or process owners, action owners, deadlines and escalation routes. Business leaders assign ownership and resources; finding owners investigate root causes, develop and implement CAPA and demonstrate effectiveness. Quality owns findings within its processes. Challenge inadequate responses and escalate unassigned, overdue, repeat or high-risk findings to the Head of USOQ and Corporate Quality Audit Sponsor, as appropriate. Honor health authority deadlines
• Independently assess audit and self-inspection responses and verify remediation effectiveness before closing findings under approved procedures. Require additional evidence or action where needed. For inspection observations, coordinate completion and effectiveness checks while preserving authorized response approvals and health authority closure decisions. Reviewers must not assess their own remediation; finding owners retain investigation, CAPA development and implementation
• Report audit themes, inspection readiness, overdue commitments and systemic risks to the Quality Council and relevant global forums. Escalate urgent risks immediately and independence concerns directly to the Corporate Quality Audit Sponsor
• Independence and Performance
• Protect audit objectivity through a documented charter, conflict disclosures, independent assignments and unfiltered reporting. Base conclusions on evidence, free from business or delivery pressures; escalate classification disputes through approved independent channels. Do not operate or approve controls the team audits; arrange independent review of its readiness and inspection-coordination activities. Track risk-based coverage, reporting and regulatory-response timeliness, readiness-gap closure, overdue and repeat findings, CAPA effectiveness and auditor competence. Do not incentivize low finding counts or guarantee inspection outcomes.

Physical Requirements

10-20% overnight travel required. This position (in-office) is located in Plainsboro, NJ.

Development Of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures and Novo Nordisk Way.

Qualifications

• Education level: Bachelor’s degree required. Advanced degree preferred; advanced degree may substitute for 2 years of experience
• Experience Level: 10+ years of progressive experience in the pharmaceutical, biotechnology, or CRO industry, including at least 5 years in GxP Quality Assurance, Compliance, or related functions, and 5 years in people leadership or leading complex cross-functional quality initiatives. Demonstrated experience in commercial/affiliate quality, pharmacovigilance quality, regulatory inspections, and pharmaceutical Quality Management Systems (QMS). Broader GDP/GMP experience preferred.
• Specific or technical job skills: Deep expertise in GxP and FDA inspections; working knowledge of GPV/GDP/GMP/GCP and other requirements applicable to commercial & post-marketing operations. Demonstrated leadership of independent audits, self-inspection programs, inspection readiness and health authority inspections, including finding classification, root-cause/CAPA challenge and effectiveness verification. Ability to distinguish inspection coordination from business execution and authorized regulatory commitments

   

   

  The base compensation range for this position is $187,100K to $327,000K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. 

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.