pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Associate Director - GCP Quality and Compliance
August 21
🏡 Remote – New York
pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Description
• Support the audit program and clinical projects to ensure compliance with regulations and Precision procedures. • Perform ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations. • Lead the oversight of a Quality Management Systems inclusive of SOPs, Training and CAPAs. • Audit regulatory documents for submission to the FDA and global regulatory authorities. • Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
Requirements
• 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance • Working knowledge of GCP/ICH guidelines and FDA regulations • Bachelor’s degree in a science, healthcare or related field of study • Availability to travel up to 25% domestically and/or internationally • Graduate, postgraduate degree, ideally in a scientific or healthcare discipline (preferred) • CRO, Pharmaceutical and/or Medical device experience (preferred) • Supervisory/management experience (preferred)
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
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