Manager, Quality Assurance - GxP (GCP Auditing) 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

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 and understanding of GMP/GDP regulations and compliance regulatory requirements.
• Experience conducting audits (GMP, GDP, electronic system audits), documenting and communicating audit results to relevant stakeholders and ensuring CAPAs are generated thorough and brought to closure.
• Demonstrated ability to perform QA reviews of SOPs, audit-related documentation, and other documents as necessary.
• Demonstrated ability to work collaboratively with internal and external key stakeholders to facilitate continuous process improvement activities.
• Ability to contribute to the identification and generation of metrics that help drive GMP/GDP process improvements and increase compliance.
•  Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with problem solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

 *Special knowledge or skills and/or licenses or certificates preferred.

• Experience writing and reviewing SOPs which support GMP/GDP audit activities/functions. § Registered GxP Quality Assurance Certifications.
•  Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.
• Knowledge and experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GVP).
• * Travel requirements Up to 45%

Expected Base Salary Range

$107,100 – 134,800.  The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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