Associate Director, Quality Validation

Minimum of 10 years of progressive GMP Quality experience within the pharmaceutical or biotechnology industry, including experience supporting late-stage development and commercial products.

Demonstrated experience leading validation programs for drug substance, drug product, packaging, and distribution operations.

Strong knowledge of process validation lifecycle principles, including PPQ, CPV, cleaning validation, packaging validation, and transportation validation.

Experience providing quality oversight of CMOs and packaging organizations.

Experience supporting regulatory inspections and maintaining inspection readiness for domestic and international health authorities.

Working knowledge of applicable global GMP regulations and guidance, including FDA, EMA, ICH, Health Canada, MHRA, PMDA, and other relevant regulatory requirements.

The Associate Director, Quality Validation is responsible for providing strategic quality leadership and oversight of validation programs supporting Drug Substance (DS), Drug Product Intermediate (DPI), Drug Product (DP), packaging, and distribution activities across the company’s global network of CDMOs, packaging partners, and suppliers.

This role ensures validation activities are scientifically sound, risk-based, compliant with cGMP requirements, and aligned with global regulatory expectations throughout the product lifecycle.

As a key member of the Quality organization, the Associate Director, Quality Validation partners closely with cross-functional teams within Pharmaceutical Development & Manufacturing (PDM) and external partners to develop and maintain robust validation strategies, support commercial manufacturing and product disposition activities, drive continuous improvement, and ensure consistent execution of validation programs across the global external manufacturing network.

Provide QA oversight and approval of validation lifecycle activities, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), cleaning validation, packaging validation, transportation/shipping validation, and ongoing process monitoring programs.

Oversee validation strategies and programs to ensure they remain scientifically sound, risk-based, and compliant with global regulatory requirements and industry best practices.

Ensure consistency and harmonization of validation approaches across multiple manufacturing and packaging sites.