Associate Director, Quality Validation

The Opportunity:

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.

Key Responsibilities:

• 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.

• Provide QA review and approval of validation protocols, reports, risk assessments, technical studies, and supporting documentation associated with commercial manufacturing operations.

• Partner with QA Operations to support batch disposition decisions by assessing validation status, process performance trends, and quality event impact on product quality.

• Monitor and trend CPV data, validation metrics, and quality performance indicators to identify emerging risks, drive continuous improvement, and ensure continued process control.

• Lead and participate in project team meetings with CDMOs, packaging vendors and suppliers to ensure alignment on validation requirements, compliance expectations, and operational readiness.

• Support the development, review, implementation, and continuous improvement of GMP quality systems, policies, procedures, and validation standards.

• Collaborate with cross-functional teams to provide technical quality guidance during product development, technology transfers, process improvements, lifecycle management activities, and commercial manufacturing operations.

• Support regulatory inspections, agency interactions, and regulatory submissions by providing validation expertise and reviewing documentation as applicable.

• Lead, mentor, and develop Quality Validation personnel to drive compliance, operational excellence, and continuous improvement.

Required Skills, Experience and Education:

• Bachelor’s degree in a scientific, engineering, or technical discipline.

• 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.

• Demonstrated ability to evaluate complex technical and compliance issues, perform risk assessments, and make sound quality decisions.

• Excellent leadership, communication, collaboration, and stakeholder management skills with the ability to influence cross-functional and external teams.

• Proven ability to manage multiple priorities, work independently, and thrive in a fast-paced environment.

• Proficiency with electronic quality systems and Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Visio.

Preferred Skills:

• Prior leadership experience managing, mentoring, and developing Quality professionals.

• Strong technical understanding of pharmaceutical manufacturing processes, process development, validation, and analytical testing; experience in small molecules is a plus.

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