Full-Time Director, Quality Assurance - GxP (GCP)

Director, Quality Assurance – GxP (GCP)

Manages GxP Quality Assurance (QA) functions with emphasis on Good Clinical Practice (GCP). Collaborates with cross-functional teams to evaluate processes, procedures, and activities for adherence to industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs).

Partners with Clinical Development/Operations and actively participates on clinical study teams to ensure GCP compliance.

Identifies and communicates 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.

Qualifications

Bachelor’s degree in a scientific discipline.

Minimum 10 years of progressively responsible experience in QA or related role.

Minimum 5 years of clinically focused position.

Detailed knowledge of GCP regulations.

Experience leading and/or conducting QA audits.

Experience developing and executing risk-based audit plans.

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.

Proficient with Microsoft Office.

Excellent verbal and written communication skills.

Ability to work independently and collaboratively.

Analytical thinker with excellent problem-solving skills.

Excellent planning, organization, and time management skills.

Knowledge of GMP, GLP, and/or GVP regulations.

GxP Quality Assurance Certifications.

Clinical lab experience.

Up to 30% Travel Expected.

Requirements

Base Salary Range: $191,700 – 241,300

Short- and long-term incentives offered.

Eligible for medical, dental, vision, and retirement savings plans.

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