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Job description
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
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Worksite address
princeton, NJ, 08543, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.