Job Description

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.

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