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

Position Overview

• Location Type:
• Job Type: Full time
• Salary:

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life’s moments for children and adults living with rare diseases. We foster an inclusive culture where everyone feels valued, respected, and empowered.

Job Description Summary

The Manager, Quality Assurance – GxP Auditing (GMP-GDP) is responsible for executing GxP Quality Assurance (QA) auditing functions, with a focus on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems governing compliance programs for commercial and clinical activities. This role involves collaboration with internal cross-functional teams to evaluate CMC processes, procedures, and activities for adherence to industry standards, regulatory guidelines, and company SOPs. The incumbent will contribute to the continuous improvement of a risk-based audit program, qualification requirements, and the inspection management process. Additionally, the role supports and/or conducts internal and external GMP and GDP compliance audits of Contract Manufacturing Organizations (CMOs), vendors, laboratories, and submission documents, and assists in inspection readiness and QA activities.

Responsibilities

• Contributes to the execution of the PTC GMP/GDP audit strategy to maintain 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 CMOs, laboratories, and other vendors.
• Ensures alignment on resolution strategies and champions corrective actions until fully implemented.
• Performs inspection readiness activities and visits to ensure preparedness for regulatory authority review.
• Schedules, plans, and notifies auditees of upcoming audits in accordance with audit plans.
• Conducts audits and prepares and submits audit reports for review.
• 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 to meet regulatory compliance and corporate business requirements.
• Maintains working knowledge of current FDA, EU, and other global regulations and guidance governing GMP and GDP activities.
• Applies global regulations, agency guidelines, and internal procedures to assure compliance.
• Supports Quality Management System (QMS) implementation and Operations efforts involving GMP audit activities.
• Contributes to QA review of SOPs and documentation related to audit functions and other related documents as required.
• Contributes to GMP/GDP audit related metrics.
• Assists in identifying and communicating CMC risks.

Requirements

• 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.
• 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.

Company Information

PTC Therapeutics is a global commercial biopharmaceutical company with a commitment to extending life’s moments for children and adults living with a rare disease. 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