Director, Quality (External Manufacturing)

Position Title:    Director, Quality , External Manufacturing

Department:      Technical Operations, Quality, and Supply Chain                        

Reports To (title): Senior Director, Quality, External Manufacturing          

Location: King of Prussia, PA (hybrid work environment)

☒  Exempt        ☐  Non-Exempt

Summary of Position:

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 of External Manufacturing Quality will provide strategic leadership for external quality systems supporting commercial pharmaceutical products, medical devices, and future pipeline products with emphasis on Drug Substance. 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.  The role is also responsible for writing/reviewing/approving SOPs, QTAs, APRs, Supplier Qualification forms, Health Authority Inspections, Product Complaints, etc.

Position Responsibilities:

• Drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary 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 that is aligned with Paratek expectations.
• Represent Quality at key internal and external
• 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; assure non-conformances are properly investigated and explained, and calculations are correct. Review batch documentation and check against registered specifications prior to market release or advising rejection of batch. Ensure Paratek release documentation for each batch is accurate and filed according to
• Provide leadership for key QMS processes such as change control, investigations, deviations and complaints and support execution of the QMS related to document development, review and approval as applicable to ensure compliance is achieved and maintained (i.e. SOPs, APR, complaints, deviations, investigations).
• Act as QA SME for CMC related issues and regulatory filings, with emphasis on Drug Substance.
• Ensure that Quality Technical Agreements (QTAs) with Paratek suppliers are established, maintained, implemented, and
• Audit Service Providers and manage all follow-up activities. Perform and participate in internal and external cGxP audits as required. This includes PAI readiness.
• Participate in internal and external cGxP Health Authority inspections, as
• Conduct review of completed GxP audits to identify systemic trends requiring
• Directly interact with GxP Service Providers to drive remediation as
• Participate in Product Recalls/Withdraws, as
• Act as Senior QA leadership and review and approve Major/Critical
• Manage and develop direct report and/or mentor junior team members.
• Assess and support GMP compliance for analytical topics to maintain compliance with the principle of GMP as required by regulatory filings as well regional or national laws and guidelines.

Candidate Requirements:

• Emulates Paratek's core values - Passionate, Resourceful, Collaborative, Purposeful
• Bachelor's degree in chemistry, biology, or related discipline
• Practical experience for at least 15 years in the pharmaceutical industry specifically in the manufacturing/technical/QA functions with at least 12 or more years of direct QA experience required.
• 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 technique and microbiological testing
• Experience working with Service Providers and with managing QTAs, conducting site audits,
• Strong current knowledge of local and international regulatory and legislative requirements to ensure that technical support on all quality related matters is provided to the country.
• Familiarity with Field Alert Reporting and participation is Health Authority inspections is also required.
• Logical problem solver who can remediate issues in a timely
• Excellent organization, written/verbal communication and attention to
• Good self-starter.

Additional Information:

• Technology needs: Microsoft Office, Veeva
• Travel requirements (%): 30% as needed both domestic and international