Director, Quality Assurance - GxP (GCP) Remote

Lifelancer

full-time

Posted on: 8/18/2025

Origin: • 🇺🇸 United States

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💰 $191,700 - $241,300 per year

Lead

Google Cloud Platform

About the role

Manage GxP QA functions with an emphasis on Good Clinical Practice (GCP), compliance for both clinical and marketed products
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 and assists in helping to meet regulatory compliance and corporate business requirements
Manages, coaches and mentors direct reports
Performs other tasks and assignments as needed and specified by management

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 as well as with 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, 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
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