Novo Nordisk · 1 day ago
Senior Director, Quality - United States Operations
Plainsboro, NJ, US
Full-time
Onsite
Director/Executive
15+ years expNovo Nordisk is a company dedicated to improving patient lives through innovative healthcare solutions. The Senior Director, Quality for United States Operations is responsible for leading Good Clinical Practices and ensuring compliance across U.S. Quality while overseeing quality assurance and regulatory documentation.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
Responsibilities
Responsible for the leadership of Good Clinical (GCP), Distribution (GDP), and Manufacturing (GMP) Practices (GxP) support across U.S. Quality
Serves as the Quality Responsible Person for U.S. Operations in accordance with SOP194945
Oversees all aspects of advanced document management related to quality assurance, including Quality Docs, SOPs, ISO standards, contracts, promotional material, and regulatory documentation
Provides strategic vision, leadership, and direction for the U.S. Quality Unit and contributes to the strategic direction of CMR Strategic Operations and Operations and Staff Quality
Represents the U.S. in relevant global committees and meetings (e.g., R&D Quality, Global GCP Compliance Focus Group, Global Operation Quality Leadership Team Meetings, Quality Leadership Summit)
Leads and implements an effective and compliant Quality Management System (QMS) across U.S. Quality, ensuring alignment with global expectations and partnerships
Serves as the key contact for all U.S. FDA GxP inspections, including GCP, PV, and Devices
Works closely with Regulatory Affairs leadership during inspections
Additionally responsible for oversight of U.S. Patient Safety outsourcing and compliance, including internal pharmacovigilance process adherence, vendor oversight, and CRO oversight
Leads the U.S. self-inspection program, ensuring a robust system of internal quality evaluation and continuous improvement
Provides direction on Product Quality, GCP compliance, and vendor management/vendor audits
Represents U.S. Quality in Global Operations Quality Leadership Team Meetings
Accountable for strategy, timelines, resource deployment, and risk management for the function
Ensures U.S. regulatory insights inform Enterprise Quality and R&D Quality strategic initiatives
Manages the functional budget, including expenses and contracts
Ensures compliance with the Novo Nordisk QMS and drives a strong Quality Mindset across U.S. Quality and CMR
Motivates teams to deliver high-quality results
Balances competing stakeholders needs and facilitates issue escalation as needed
Leads senior management initiatives related to GCP and QA compliance and continuous improvement
Accountable for achievement of productivity metrics for the function
Directs the development and maintenance of SOPs documenting compliance with corporate and regulatory requirements
Leads the development and execution of the U.S. GxP audit plan
Oversees internal audits and external inspections (e.g., FDA) across all GxP areas
Leads the U.S. self-inspection program, including planning, execution, reporting, CAPA oversight, and trend evaluation
Oversees execution of Quality Management Review (QMR) and follow-up actions
Ensures Quality support to U.S. manufacturing facilities, product warehouses, and Supply Chain to enable product release to the U.S. market
Oversees development and tracking of Quality activities across U.S. Operations
Provides Quality reporting to U.S. Executive Teams, including QAP and QMR
Qualification
Required
Bachelor's degree required; relevant experience may be substituted for degree, when appropriate; advanced degree preferred
A minimum of 15 years progressively increasing relevant experience preferably in QA and/or GCP; pharma industry preferred with a minimum of 8 years of Quality related experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting
A minimum of 5 years supervisory experience required
Demonstrated experience with different GxP areas and core expertise with relation to FDA and other health authority inspections
Strong analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from international representation at a senior management level
Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
Company
Novo Nordisk
Novo Nordisk is a healthcare company that produces and distributes insulin and other diabetes drugs to treat chronic diseases.
10001+ employees
H1B Sponsorship
Novo Nordisk has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (21)
2023 (13)
2022 (10)
2021 (9)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$22M2018-12-05Post Ipo Equity· $22M
1981-07-09IPO
Leadership Team
Lars Fruergaard Jørgensen
President and CEO
Lars Sorensen
President & CEO
Recent News
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