Senior Manager - Quality Assurance - GxP (GLP Focus)

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.

About the role

The Senior Manager, Quality Assurance - GxP (GLP Focus) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Laboratory Practice (GLP) compliance for development products. This role involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs). The incumbent will manage direct reports and provide QA oversight and support for an in-house GLP bioanalytical laboratory and outsourced toxicology and bioanalytical studies.

Responsibilities

• Partner with PreClinical Development Drug Metabolism and Pharmacokinetics (DMPK), Toxicology, Pharmacology and Biomarker, and early development departments to ensure GLP compliance.
• Review and approve study-related documents and plans including method development, method validation, and study data.
• Manage and perform internal and external audits to ensure compliance with GxP regulations and guidelines, including in-phase study, internal processes, data, and vendors.
• Communicate audit results to internal stakeholders and write audit reports.
• Assess audit responses and ensure closure of corrective action preventative actions (CAPAs).
• Participate in regulatory authority inspections and lead GxP inspection readiness activities.
• Manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

Requirements

• Bachelor’s degree in a scientific discipline and a minimum of 7 years of relevant experience in Quality Assurance or a related role in a pharmaceutical, biotechnology, or related environment.
• Detailed knowledge and understanding of GLP and OECD 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 as well as external, third-party vendors.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• 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 consisting of internal and external team members.
• 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.

Preferred Qualifications

• Experience writing and reviewing SOPs.
• Bioanalytical lab experience.
• Registered GxP Quality Assurance Certifications.
• Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.
• Knowledge and experience in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and/or Good Pharmacovigilance Practice (GVP) regulations.

Pay

Expected base salary range: $139,700 - $175,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position, as well as review of internal equity. In addition to base salary, PTC employees are eligible for short- and long-term incentives.

Benefits

All eligible employees may enroll in PTC’s medical, dental, vision, and retirement savings plans.

Schedule

Travel requirements: Up to 30%.