Manager, Quality Assurance – GxP Auditing (GMP-GDP) - Remote

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

Job Description:

The Manager, Quality Assurance – GxP Auditing (GMP-GDP) is responsible for executing GxP Quality Assurance (QA) auditing functions with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for commercial and clinical activities.

This involves engaging and collaborating with cross functional internal teams to evaluate CMC processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

The incumbent is responsible for continuous improvement of a risk-based audit program, qualification requirements for audits, and the inspection management process. In addition, the incumbent supports and/or conducts internal and external GMP and GDP compliance audits of Contract Manufacturing Organizations (CMOs), vendors, laboratories, submission documents etc. and assists in inspection readiness activities, Quality Assurance activities and the development and review of SOPs.

The incumbent works cross-functionally with internal departments and external resources on GMP/GDP QA related issues and may assume additional responsibilities as required.

Responsibilities

• Contributes to the execution of the PTC GMP/GDP audit strategy to maintain GMP/GDP compliance with applicable regulations, guidelines, and current regulatory requirements.
• Performs assigned internal and external audits to assure compliance with GMP and GDP regulations; evaluates the quality systems of Contract Manufacturing Organizations (CMOs), laboratories and other vendors and ensures that alignment is achieved regarding resolution strategies; champions corrective actions until fully implemented; performs inspection readiness activities and visits to ensure preparedness for regulatory authority review. This includes, but may not be limited to, the following activities:
  • Schedules, plans, and notifies auditee of an upcoming audit in accordance with audit plans.
  • Conducts audit(s) and prepares and submits audit reports for review and input.

• Communicates audit results to stakeholders.
• Assesses audit responses and collaborates with CMC colleagues and QA supervision to develop and ensure closure of CAPA plans.
•  Assists with GxP inspection readiness activities for regulatory authority inspections and coordinates tracking of document requests, responses and supporting documentation during inspections.
• Contributes to PTC’s understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements. This includes, but may not be limited to, the following activities:
  • Maintains working knowledge of current FDA, EU and other global regulation and guidance governing Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) activities.
  • Applies global regulation, agency guidelines and internal procedures to assure compliance.
• Supports Quality Management System (QMS) implementation and Operations efforts involving GMP audit activities. This includes, but may not be limited to, the following activities:
  •  Contributes to QA review of SOPs and documentation related to audit functions, as well as other related documents as required by regulation and as appropriate.
  • Contributes to GMP/GDP audit related metrics.
  • Assists in identifying and communicating CMC risks and opportunities for process improvement as determined through audit activities.
  • Contributes to Corrective and Preventive Actions activities resulting from audits.

Qualifications

• Bachelor’s degree in scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance, Regulatory Affairs, Manufacturing, or a related role in a pharmaceutical, biotechnology or related environment.
• Demonstrated ability to work as a team player, listens, promotes exchanges, communicates, adapts, and advises.
•  Demonstrated knowledge a