Senior Director, Quality
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Plainsboro • New Jersey • United States
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Job Level
Tech Stack
About the role
- 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.
Requirements
- 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)
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Good Clinical Practices (GCP)Good Distribution Practices (GDP)Good Manufacturing Practices (GMP)Quality Assurance (QA)Regulatory CompliancePharmacovigilanceDocument ManagementISO StandardsQuality Evaluation
Soft Skills
LeadershipAnalytical SkillsNegotiationMeeting ManagementCross-Functional Team CollaborationStrategic VisionDirection SettingContinuous ImprovementCommunicationInternational Representation