GTS Scientific
Executive Director/VP Quality and Regulatory
GTS Scientific, Princeton, New Jersey, us, 08543
Executive Director/VP Quality and Regulatory
Executive Director/VP Quality and Regulatory
Direct message the job poster from GTS Scientific Executive Director/VP Quality and Regulatory Location:
On-site (with flexibility for hybrid work) Travel:
~15–20% domestic/international Position Summary A growing, global contract services provider in the pharmaceutical industry is seeking an accomplished Executive Director/VP Quality and Regulatory. This executive leader will oversee the Quality Assurance, Quality Control, and Regulatory Affairs functions for a dynamic organization focused on commercial drug manufacturing and clinical trial supply chain services. The role requires deep expertise in global regulatory compliance (FDA, EMA, etc.), strong leadership in quality systems, and experience navigating both commercial and clinical operations within a regulated GxP environment. Strategic Leadership Define and execute the Quality and Regulatory strategy in alignment with enterprise growth goals. Participate in senior leadership forums to guide overall business direction and risk management. Serve as the primary Quality and Regulatory representative in client, regulatory, and external stakeholder engagements. Quality Assurance & Systems Lead quality oversight across manufacturing, packaging, labeling, and distribution. Ensure compliance with cGMP (21 CFR Parts 210/211), EU GMPs, and ICH standards. Maintain audit readiness and drive continuous improvement across all quality operations. Track and enhance quality performance metrics (e.g., deviations, CAPAs, complaint trends). Regulatory Affairs Develop and manage regulatory compliance strategies across all product lifecycle stages. Interpret and implement evolving global regulatory requirements. Direct preparation of regulatory filings including site registrations and amendments. Act as a liaison with regulatory agencies and client representatives. Clinical Supply Chain Compliance Ensure compliance with GCP, GMP, and GDP in clinical packaging, labeling, and distribution. Oversee qualification of depots, shipping lanes, and cold chain systems. Maintain controls over investigational product handling, reconciliation, and destruction. Leadership & Talent Development Lead and develop a high-performing, technically strong Quality & Regulatory team. Ensure team resourcing, capability building, and training keep pace with company growth. Promote cross-functional collaboration with operations, supply chain, and commercial teams. Qualifications Education Bachelor’s degree in a scientific or technical field required (Pharmacy, Chemistry, Biology, Engineering, etc.) Advanced degree (MS, PharmD, PhD, MBA) preferred. Experience 15+ years of progressive leadership in pharmaceutical quality and regulatory functions. Minimum 5 years in an executive/senior leadership role. Experience in a contract development and manufacturing or clinical supply environment is strongly preferred. Demonstrated success managing global regulatory inspections and audits. Familiarity with sterile, oral solid dose, or biologic drug manufacturing is a plus. Core Competencies Expert knowledge of cGMP, GDP, GCP, ICH, and global regulatory expectations. Strategic and operational leadership with executive presence. Strong decision-making, analytical thinking, and communication skills. Proven ability to thrive in a fast-paced, client-driven organization. Seniority level
Seniority level Executive Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GTS Scientific by 2x Get notified about new Vice President of Quality jobs in
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Executive Director/VP Quality and Regulatory
Direct message the job poster from GTS Scientific Executive Director/VP Quality and Regulatory Location:
On-site (with flexibility for hybrid work) Travel:
~15–20% domestic/international Position Summary A growing, global contract services provider in the pharmaceutical industry is seeking an accomplished Executive Director/VP Quality and Regulatory. This executive leader will oversee the Quality Assurance, Quality Control, and Regulatory Affairs functions for a dynamic organization focused on commercial drug manufacturing and clinical trial supply chain services. The role requires deep expertise in global regulatory compliance (FDA, EMA, etc.), strong leadership in quality systems, and experience navigating both commercial and clinical operations within a regulated GxP environment. Strategic Leadership Define and execute the Quality and Regulatory strategy in alignment with enterprise growth goals. Participate in senior leadership forums to guide overall business direction and risk management. Serve as the primary Quality and Regulatory representative in client, regulatory, and external stakeholder engagements. Quality Assurance & Systems Lead quality oversight across manufacturing, packaging, labeling, and distribution. Ensure compliance with cGMP (21 CFR Parts 210/211), EU GMPs, and ICH standards. Maintain audit readiness and drive continuous improvement across all quality operations. Track and enhance quality performance metrics (e.g., deviations, CAPAs, complaint trends). Regulatory Affairs Develop and manage regulatory compliance strategies across all product lifecycle stages. Interpret and implement evolving global regulatory requirements. Direct preparation of regulatory filings including site registrations and amendments. Act as a liaison with regulatory agencies and client representatives. Clinical Supply Chain Compliance Ensure compliance with GCP, GMP, and GDP in clinical packaging, labeling, and distribution. Oversee qualification of depots, shipping lanes, and cold chain systems. Maintain controls over investigational product handling, reconciliation, and destruction. Leadership & Talent Development Lead and develop a high-performing, technically strong Quality & Regulatory team. Ensure team resourcing, capability building, and training keep pace with company growth. Promote cross-functional collaboration with operations, supply chain, and commercial teams. Qualifications Education Bachelor’s degree in a scientific or technical field required (Pharmacy, Chemistry, Biology, Engineering, etc.) Advanced degree (MS, PharmD, PhD, MBA) preferred. Experience 15+ years of progressive leadership in pharmaceutical quality and regulatory functions. Minimum 5 years in an executive/senior leadership role. Experience in a contract development and manufacturing or clinical supply environment is strongly preferred. Demonstrated success managing global regulatory inspections and audits. Familiarity with sterile, oral solid dose, or biologic drug manufacturing is a plus. Core Competencies Expert knowledge of cGMP, GDP, GCP, ICH, and global regulatory expectations. Strategic and operational leadership with executive presence. Strong decision-making, analytical thinking, and communication skills. Proven ability to thrive in a fast-paced, client-driven organization. Seniority level
Seniority level Executive Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GTS Scientific by 2x Get notified about new Vice President of Quality jobs in
Princeton, NJ . Whitehouse Station, NJ $140,000.00-$238,000.00 3 weeks ago Princeton, NJ $154,400.00-$280,000.00 1 week ago VICE PRESIDENT, CHIEF MEDICAL OFFICER (CMO), CARRIER CLINIC CHAIR, PSYCHIATRY, CHAIR
Cranbury, NJ $150,000.00-$180,000.00 3 weeks ago Cranbury, NJ $294,000.00-$352,666.00 1 week ago Cranbury, NJ $150,000.00-$200,000.00 2 weeks ago Director of Contract Manufacturing & Commercialization
New Brunswick, NJ $120,000.00-$170,000.00 1 week ago Associate Director of Quality - Process Analytics
Director Quality, Safety and Regulatory (RN)
Somerville, NJ $130,000.00-$180,000.00 1 week ago Vice President of Ambulatory Operations, Jack & Sheryl Morris Cancer Center
New Brunswick, NJ $175,000.00-$335,000.00 1 week ago Princeton, NJ $332,500.00-$406,000.00 2 months ago Vice President, Head of US Data Governance
Iselin, NJ $185,000.00-$205,000.00 2 weeks ago Senior Director, Manufacturing Science and Technology
Hopewell, NJ $203,800.00-$273,800.00 5 days ago Vice President/Chief Operating Officer - Radiopharmaceutical CDMO Operations
Regional Vice President of Operations - New York Region
Assistant Vice President, Hospital Operations - Robert Wood Johnson University Hospital
New Brunswick, NJ $175,000.00-$295,000.00 1 week ago New Brunswick, NJ $135,000.00-$200,000.00 1 week ago Director, Contracts and Transactions Counsel
Princeton, NJ $228,000.00-$307,000.00 20 hours ago Bridgewater, NJ $100,000.00-$150,000.00 2 weeks ago Children’s Specialized Hospital is seeking an Assistant Vice President (AVP) in New Brunswick, New Jersey
South Brunswick, NJ $240,000.00-$300,000.00 2 weeks ago Managing Director, Executive and Professional Search
Bridgewater, NJ $100,000.00-$150,000.00 2 weeks ago Managing Director, Executive and Professional Search
Newtown, PA $100,000.00-$150,000.00 2 weeks ago Newtown, PA $100,000.00-$150,000.00 2 weeks ago Assistant Vice President Heart and Vascular Service Line
Children’s Specialized Hospital is seeking an Assistant Vice President (AVP) in New Brunswick, New Jersey
New Brunswick, NJ $240,000.00-$400,000.00 1 week ago NB1482 AVP Quality Control Portfolio Analyst
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr