PTC Therapeutics, Inc.
Director, Quality Assurance - GxP (Project Management)
He/She may manage direct reports.
The incumbent works cross-functionally with internal departments and external resources on Quality related issues.
The Director, Quality Assurance - GxP ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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 audit strategy to achieve compliance with applicable current regulatory requirements.
Performs internal and external audits as assigned to assure compliance with GCP regulations and guidelines (may include internal processes, regulatory filings, Clinical Research Organizations (CROs), investigator sites, and other vendors)
o Communicates audit results to internal stakeholders and writes audit report.
o Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
Leads backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.
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.
Qualifications:
Bachelor's degree in a scientific discipline and a minimum of 8 years progressively responsible experience in a QA or related role in a pharmaceutical or biotechnology organization and 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 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.
Knowledge and experience in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP) regulations preferred.
Registered GxP Quality Assurance Certifications preferred.
Clinical lab experience preferred.
Up to 30% Travel involved post covid.
Office/Remote position
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page