Director, Quality (External Manufacturing)

King of Prussia, PA (hybrid work environment) | Exempt

About the role

The Director of External Manufacturing Quality is responsible for leading and overseeing 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 where applicable. The Director provides strategic leadership for external quality systems supporting commercial pharmaceutical products, medical devices, and future pipeline products. The position partners 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.
• 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 audited; 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.
• Conduct review of completed GxP audits to identify systemic trends requiring remediation.
• Directly interact with GxP Service Providers to drive remediation.
• Participate in product recalls/withdrawals as needed.
• Act as Senior QA leadership and review/approve Major/Critical investigations.
• 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

• Emulates core values: Passionate, Resourceful, Collaborative, Purposeful.
• Bachelor’s degree in chemistry, biology, or related discipline.
• Minimum 15 years of experience in the pharmaceutical industry, with at least 12 years in QA functions, specifically in manufacturing/technical/QA roles.
• 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.
• 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 with the ability to remediate issues in a timely manner.
• Excellent organization, written/verbal communication, and attention to detail.
• Self-starter with strong initiative.

Schedule

30% travel required, both domestic and international.

Technology

Microsoft Office, Veeva