Senior Manager, Quality Assurance - GxP (GCP)- Remote
PTC Therapeutics, Inc | |
United States | |
Sep 29, 2024 | |
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:
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.
*Special knowledge or skills and/or licenses or certificates preferred.
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. Click here to return to the careers page |