<p>Position Title: Manager, Quality</p> <p>Department: Chemistry, Manufacturing, and Controls (CMC) and Quality</p> <p>Reports To (title): Senior Director, Quality</p> <p>Location: King of Prussia, PA (hybrid work schedule)</p> <p>Date: June 2025</p> <p>Summary of Position:</p> <p>The Manager, Quality is responsible for supporting the Quality team in accordance with cGMPs and Standard Operating Procedures and maintaining company Quality Systems related to clinical and commercial development/manufacturing/testing. Specifically, responsible for ensuring that investigational and commercial drug products are manufactured, tested, analyzed, packed and released for use in clinical trials and/or to market in accordance with their requirement's and/or registered approvals and in compliance with the principles of cGMP. The Manager, Quality will be responsible for the general oversight of the Paratek Document Management System, batch release activities, assisting in Health Authority inspections, leading Service Provider audits, leading and generation of the Annual Product Review (APR) process, updating/maintenance of QTAs, processing product quality complaints, and assisting other on-going quality initiatives, as needed.</p> <p>Position Responsibilities:</p> <ul> <li>Independently review and release (ensuring complete knowledge and full understanding) drug substance/drug product materials in a timely manner; assures non-conformances are investigated and acceptable and calculations are correct. Review finished product packs and batch documentation and check against registered specifications prior to market release or advising rejection of batch. Ensures Paratek release documentation for each batch is accurate and filed appropriately post release. </li><li>Facilitates inspection readiness efforts ensuring compliance and quality of essential documents. Participants in health authority inspections including leading processing product quality complaints and any follow-up activities associated with an inspection, as applicable. </li><li>Manages/leads all aspects of Paratek Document Management System/Veeva activities, including processing and closure of internal and Service Provider change controls, deviations, CAPAs and effectiveness checks. </li><li>Leads, authors and reviews applicable sections of the Paratek Annual Product. </li><li>Participates in weekly meetings with CMO's and works with management to resolve any continuous supply issues, material issues or any other general compliance concerns. </li><li>Learns technical process and reviews CMOs change controls and deviations. Responsible for closure of change controls, CAPAs and effectiveness checks. </li><li>Independently leads cGMP and cGXP audits of applicable Paratek Service Providers, including agenda author/review, issues/reviews report and any applicable follow up options. Tracks and trends audit outcomes. </li><li>Responsible for reviewing and supporting QTAs for Service Providers. </li><li>Acts as point of contact and maintains a good working relationship with Paratek Service Providers for quality matters. </li><li>Using creative and independent problem-solving skills, finds ways to resolve Quality issues as they arise. </li><li>Provides general support to the GMP/GCP QA team as needed. </li><li>Performs other tasks as needed to support Quality. </li></ul> <p>Candidate Requirements:</p> <ul> <li>Emulates Paratek's core values - Passionate, Resourceful, Collaborative, Purposeful </li><li>Bachelor's degree or equivalent education and experience required. </li><li>Practical experience for at least 5 years in the pharmaceutical industry specifically 3 years in the manufacturing/technical/QA space. </li><li>Excellent organizational and time management skills, written and verbal communication, and professional demeanor. </li><li>Demonstrated flexibility and professional maturity to proactively and readily understand priorities and anticipate needs. </li><li>Team player and ability to work well independently. </li><li>Ability to effectively multi-task with a willingness to identify and perform a wide range of tasks with a positive "can do" attitude. </li><li>Willingness to learn and grow to understand quality plus a desire to develop skills to increase effectiveness. </li><li>Experience working with contractors and with managing QTAs, conducting site audits, etc. </li><li>Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country. </li></ul> <p>Additional Information:</p> <ul> <li>Technology needs: Microsoft Office (Outlook, Word, Excel, PowerPoint, Veeva) </li><li>Travel requirements (%): 25-30% both domestic and international </li></ul>