Manager, Quality Assurance - GxP (GCP Auditing) 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 cultivate an inclusive culture where everyone feels valued, respected, and empowered. Visit our website to learn more about our company and culture: www.ptcbio.com

Job Description

The Manager, Quality Assurance – GxP Auditing (GMP-GDP) is responsible for executing GxP Quality Assurance (QA) auditing functions, with a strong emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for commercial and clinical activities. This role involves collaboration with cross-functional internal teams to evaluate CMC processes, procedures, and activities for adherence to industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs).

The incumbent will contribute to the continuous improvement of a risk-based audit program, qualification requirements for audits, 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 activities, Quality Assurance tasks, and the development and review of SOPs. The role requires cross-functional collaboration with internal departments and external resources on GMP/GDP QA-related issues, with the potential for assuming additional responsibilities.

Responsibilities

• Contributes to the execution of the PTC GMP/GDP audit strategy to ensure 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.
• 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/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

• [Specific requirements will be listed here once provided]

Application Instructions

• [Application instructions will be listed here once provided]

Company Information

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