Director of Quality

King of Prussia, PA • Exempt

About the role

The Director of External Manufacturing Quality leads and oversees quality activities across contract manufacturing organizations (CMOs), contract laboratories, suppliers, and external partners supporting the company's clinical and commercial pharmaceutical and medical device portfolio with emphasis on Drug Substance. This role ensures compliance with global regulatory requirements, maintains product quality, and drives continuous improvement. The Director provides strategic leadership for external quality systems supporting commercial pharmaceutical products, medical devices, and future pipeline products, partnering closely with Technical Operations, Quality Management System, Supply Chain, Regulatory Affairs, Development, and Commercial to ensure uninterrupted product supply and regulatory compliance.

Responsibilities

• Drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations to improve relationship performance against agreed-upon metrics and business goals.
• Serve as the primary quality representative for strategic supplier and CMO relationships.
• Work with Contract Manufacturing Organizations (CMOs) to develop a quality culture aligned with company expectations.
• Represent Quality at key internal and external meetings.
• Review and approve investigations, deviations, CAPAs, change controls, and product impact assessments originating from external partners.
• Perform thorough batch record review and release in an efficient and timely manner; ensure non-conformances are properly investigated, calculations are correct, and batch documentation is checked against registered specifications prior to market release.
• Provide leadership for key QMS processes such as change control, investigations, deviations, and complaints; support execution of the QMS related to document development, review, and approval (e.g., SOPs, APRs, complaints, deviations, investigations).
• Act as QA subject matter expert (SME) for CMC-related issues and regulatory filings, with emphasis on Drug Substance.
• Ensure Quality Technical Agreements (QTAs) with suppliers are established, maintained, implemented, and revised.
• Audit service providers and manage all follow-up activities; perform and participate in internal and external cGxP audits, including PAI readiness.
• Participate in internal and external cGxP Health Authority inspections as required.
• Conduct review of completed GxP audits to identify systemic trends requiring remediation; interact directly with GxP service providers to drive remediation.
• Participate in product recalls/withdrawals as required.
• Act as Senior QA leadership and review/approve major/critical deviations.
• Manage and develop direct reports and/or mentor junior team members.
• Assess and support GMP compliance for analytical topics to maintain compliance with regulatory filings, regional or national laws, and guidelines.

Requirements

• Bachelor’s degree in chemistry, biology, or related discipline.
• Minimum 15 years of experience in the pharmaceutical industry, with at least 12 years in direct QA roles within manufacturing, technical, or QA functions.
• Strong working knowledge of US cGMPs for clinical and commercial pharmaceutical and medical device portfolio, with emphasis on Drug Substance.
• Strong understanding of analytical method validation, pharmaceutical drug substance/drug product analytical techniques, and microbiological testing requirements.
• Experience working with service providers, managing QTAs, and conducting site audits.
• Current knowledge of local and international regulatory and legislative requirements; familiarity with Field Alert Reporting and participation in Health Authority inspections.
• Logical problem solver capable of remediating issues in a timely fashion.
• Excellent organization, written/verbal communication, and attention to detail.
• Self-starter with demonstrated initiative.

Skills

• Microsoft Office, Veeva

Schedule

30% travel as needed, both domestic and international.