Director, Quality Assurance – GxP (GCP) - Remote

Overview

The Director, Quality Assurance – GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP), compliance for both clinical and marketed products. This involves engaging and collaborating with cross-functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate.

In Short

• 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.
• 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.
• Manages, coaches and mentors direct reports.
• Performs other tasks and assignments as needed and specified by management.

Requirements

• Bachelor’s degree in a scientific discipline.
• Minimum of 10 years progressively responsible experience in a QA or related role in a pharmaceutical or biotechnology organization.
• At least 5 years 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 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.
• Excellent planning, organization and time management skills.
• Knowledge and experience in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP) regulations.
• Registered GxP Quality Assurance Certifications.
• Clinical lab experience.
• Up to 30% Travel Expected.

Benefits

• Comprehensive health insurance.
• 401(k) with company match.