Manager, Quality Assurance - GxP

March 26

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PTC Therapeutics, Inc.

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PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.

Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives

501 - 1000 employees

Founded 1998

📋 Description

• Responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Pharmacovigilance Practice (GVP) compliance for pre- and post-marketed products. • QA oversight and support of pharmacovigilance function. • Engage and collaborate with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards. • Assist in inspection readiness activities. • Support and/or conduct internal and external/vendor GVP audits of pharmacovigilance processes, safety vendors, distributors, market research vendors, patient support programs, etc. • Support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. • Partners with Pharmacovigilance function to ensure GVP compliance. • Assists in identifying and communicating pharmacovigilance-related risks and opportunities for process improvement. • Performs internal and external audits as assigned to assure compliance with GVP regulations and guidelines. • Communicates audit results to internal stakeholders and writes audit reports. • Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs). • Participates in regulatory authority inspections and assists with GxP inspection readiness activities. • Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service. • Ensures appropriate and timely escalation of quality issues, including issues of significant deviations to QA Management. • Engages in quality system continuous improvement initiatives to enforce the quality culture. • Perform other tasks and assignments as needed and specified by management.

🎯 Requirements

• Bachelor’s degree in scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment. • Knowledge and understanding of global GVP regulations, predominantly EMA and FDA. • Experience leading and/or conducting QA audits. • Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors. • Proficiency with Microsoft Office. • Excellent verbal and written communication and 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 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. • Special knowledge or skills and/or licenses or certificates preferred. • Pharmacovigilance (PV) Operations experience. • Experience writing and reviewing SOPs. • Quality management System (QMS) management experience. • Registered GxP Quality Assurance Certifications. • Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections. • Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations.