Associate Director, Quality (QMS)

Associate Director, Quality (QMS)

The Associate Director, Quality, is responsible for overseeing, managing, and updating the Quality Management System (QMS) at Paratek to ensure it always remains fit for purpose. The role is responsible for ensuring the organization completes training, for writing / reviewing / approving procedural documents, for organizing, conducting, overseeing, tracking and trending internal and external audits, providing service provider management through writing / reviewing / approving QTAs, APRs, supplier qualification forms, etc., writing / reviewing / approving quality incidents such as deviations, FDA field alerts, product recalls, and generating metrics as needed. The role is also responsible for providing pharmacovigilance QA support and supporting Health Authority Inspections.

Position 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.

Candidate Requirements :

Additional Information :