Director, Quality Assurance - GxP (GCP) Remote

Position Overview

• Location Type: [Not Specified]
• Job Type: Full time
• Salary: [Not Specified]

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 Director, Quality Assurance – GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions, with a strong emphasis on Good Clinical Practice (GCP) compliance for both clinical and marketed products. This role involves collaborating with cross-functional internal teams to evaluate processes, procedures, and activities for adherence to industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs). The incumbent will manage direct reports and work cross-functionally with internal departments and external resources on Quality-related issues, ensuring compliance with relevant regulatory requirements and SOPs.

Responsibilities

• Partners with Clinical Development/Operations and actively participates on clinical study teams to ensure GCP compliance.
• Assists in identifying and communicating clinical trial-related risks and opportunities for process improvement.
• Reviews study-related documents and plans.
• Develops and executes PTC’s GxP risk-based study audit strategy to achieve compliance with applicable current regulatory requirements.
• Performs internal and external audits to assure compliance with GCP regulations and guidelines (may include internal processes, regulatory filings, Clinical Research Organizations (CROs), investigator sites, and other vendors).
• Communicates audit results to internal stakeholders and writes audit reports.
• Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
• Performs GxP inspection readiness activities.
• Leads front/backroom activities during regulatory authority inspections.
• Advances PTC’s understanding of worldwide regulations, guidelines, and GxP practices, assisting in meeting regulatory compliance and corporate business requirements.
• Manages, coaches, and mentors direct reports.
• Performs other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum of 10 years of progressively responsible experience in a QA or related role in a pharmaceutical or biotechnology organization.
• At least 5 years of experience in a clinically focused position.
• Detailed knowledge and understanding of GCP regulations.
• Demonstrated experience leading and/or conducting QA audits.
• Demonstrated experience developing and executing risk-based audit plans.
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff and external, third-party vendors.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to influence without direct authority.
• Experience supporting regulatory agency inspections.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment.
• Analytical thinker with excellent 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.
• Knowledge and experience in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP) is a plus.

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: www.ptcbio.com