Associate Director, Quality (QMS)

<p><em>Position Title:    Associate Director, Quality         </em></p> <p><em>Department:      Chemistry, Manufacturing and Controls (CMC) and Quality                        </em></p> <p><em>Location: King of Prussia, PA (hybrid)</em></p> <p><em>Date:    October 2025    </em></p> <p><em>Summary of Position: </em></p> <p>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.</p> <p><em>Position Responsibilities: </em></p> <ul> <li>Provide leadership and oversight for all QMS processes.</li> <li>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.</li> <li>Represent Quality at key internal and external</li> <li>Ensure execution of the QMS related to document development, review and approval as applicable to ensure compliance is achieved and maintained including:</li> <li>Ensure annually training is completed on time.</li> <li>Ensure annually all procedural documents are written/reviewed/approved.</li> <li>Ensure annually all Annual Product Reviews (APRs) are written/reviewed/approved.</li> <li>Ensure that Quality Technical Agreements (QTAs) with Paratek suppliers are established, maintained, implemented, and</li> <li>Establish an annual master audit plan.</li> <li>Ensure the Qualified Service Provider List (QSPL) is reviewed and updated routinely.</li> <li>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.</li> <li>Conduct review of completed GxP audits to identify systemic trends requiring</li> <li>Participate in internal and external cGxP Health Authority inspections, as</li> <li>Directly interact with GxP Service Providers to drive remediation as</li> <li>Supports pharmacovigilance QA activities.</li> <li>Support/lead FDA field alerts, Product Recalls/Withdraws, as</li> <li>Lead continuous improvement initiatives to enhance product and service quality.</li> </ul> <p><em>Candidate Requirements:</em></p> <ul> <li>Emulates Paratek's core values - Passionate, Resourceful, Collaborative, Purposeful</li> <li>Bachelor's degree in chemistry, biology, or related discipline</li> <li>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.</li> <li>Experience working with Service Providers and with managing QTAs, conducting site audits, completing APRs,</li> <li>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.</li> <li>Familiarity with Field Alert Reporting and participation in Health Authority inspections is also required.</li> <li>Logical problem solver who can remediate issues in a timely</li> <li>Excellent organization, written/verbal communication and attention to</li> <li>Good self-starter, ability to work independently.</li> </ul> <p><em>Additional Information:</em></p> <ul> <li>Technology needs: Microsoft Office, Excel, Veeva</li> <li>Travel requirements (%): 30% as needed both domestic and international</li> </ul>