Director, Quality Assurance - GxP (GCP) Remote

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. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

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.

She/He manages direct reports.

The incumbent works cross-functionally with internal departments and external resources on Quality related issues.

The Director, Quality Assurance - GxP (GCP) 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 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.

Qualifications

• Bachelor's degree in a scientific discipline and a minimum of 10 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 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.
• Up to 30% Travel

Expected Base Salary Range:

$ 191,700 - 241,300 The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

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.

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