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Paratek Pharmaceuticals · 2 months ago

Associate Director, Quality (QMS)

King of Prussia, PA

Full-time

Hybrid

Lead/Staff, Director/Executive

15+ years exp

Paratek Pharmaceuticals is seeking an Associate Director of Quality to oversee and manage the Quality Management System (QMS). The role includes ensuring compliance through training, document management, audits, and supporting health authority inspections.

BiopharmaBiotechnologyHealth Care

Responsibilities

Provide leadership and oversight for all QMS processes

Drive collaboration within internal cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed-upon metrics and business goals

Represent Quality at key internal and external

Ensure execution of the QMS related to document development, review and approval as applicable to ensure compliance is achieved and maintained including:

Ensure annually training is completed on time

Ensure annually all procedural documents are written/reviewed/approved

Ensure annually all Annual Product Reviews (APRs) are written/reviewed/approved

Ensure that Quality Technical Agreements (QTAs) with Paratek suppliers are established, maintained, implemented, and

Establish an annual master audit plan

Ensure the Qualified Service Provider List (QSPL) is reviewed and updated routinely

Audit Service Providers and manage all initial and follow-up activities. Perform and participate in internal and external cGxP audits as required. This includes PAI readiness

Conduct review of completed GxP audits to identify systemic trends requiring

Participate in internal and external cGxP Health Authority inspections, as

Directly interact with GxP Service Providers to drive remediation as

Supports pharmacovigilance QA activities

Support/lead FDA field alerts, Product Recalls/Withdraws, as

Lead continuous improvement initiatives to enhance product and service quality

Qualification

Quality Management System (QMS)Pharmaceutical industry experienceService Provider managementRegulatory knowledgeField Alert ReportingAuditing skillsMicrosoft OfficeVeevaProblem solvingCommunication skillsOrganizational skills

Required

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 10 or more years of direct QMS QA experience required

Experience working with Service Providers and with managing QTAs, conducting site audits, completing APRs

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 in Health Authority inspections is also required

Logical problem solver who can remediate issues in a timely manner

Excellent organization, written/verbal communication and attention to detail

Good self-starter, ability to work independently

Technology needs: Microsoft Office, Excel, Veeva

Travel requirements (%): 30% as needed both domestic and international