PTC Therapeutics, Inc.
Manager, Quality Assurance - GxP (Project Management)
This role involves engaging and collaborating with cross functional internal teams to evaluate study-related processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company SOPs as appropriate.
The incumbent will support and/or conduct internal and external GCP compliance audits of investigator sites, central laboratories, Clinical Research Organizations (CROs), vendors, clinical study reports, protocol, investigator brochures, submission documents etc. and will assist in inspection readiness activities, Quality Control activities, and the development and review of SOPs.
The incumbent will work cross-functionally with internal departments and external resources on GxP QA related issues and will be accountable for the execution and closure of the assigned GXP QA audit activities ensuring the current regulations at contract facilities worldwide.
The Manager, Quality Assurance - GxP supports adherence to relevant regulatory requirements and company SOPs as appropriate.
Responsibilities:
Qualifications:
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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