Job Description Summary:
The Senior Manager, Quality Assurance - GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP) compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.
The incumbent will support and/or conduct internal and external GCP audits of investigator sites, vendors, clinical study reports, investigator brochures, and submission documents, etc.
She/He will assist in inspection readiness activities.
She/He may manage direct reports.
The incumbent works cross-functionally with internal departments and external resources on GxP QA related issues.
The Senior Manager, Quality Assurance – GxP (GCP)supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
Responsibilities:
- Partners with Clinical Development/Operations and actively participates in 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.
- Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.
- Communicates audit results to internal stakeholders and writes audit report.
- 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.
- Supports Quality Management System (QMS) including, but not be limited to, the following activities:
- QA review/approval of deviations, CAPAs and change controls.
- Drafts, reviews, and approves SOPs.
- May manage, coach, and mentor 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 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
- 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.
- 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.
*Special knowledge or skills and/or licenses or certificates preferred.
- Experience writing and reviewing SOPs.
- Clinical lab experience.
- Registered GxP Quality Assurance Certifications.
- Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.
- Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Pharmacovigilance Practice (GVP) regulations.
Travel requirements: Up to 30% -Domestic and global
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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