Executive Director, Global GMP Auditing

4 Days Old

Executive Director, Global GMP Auditing
About the Company
Industry shaping pharmaceutical company
Industry Pharmaceuticals
Type Public Company
Founded 1891
Employees 10,001+
Categories
Biotechnology Health Care Medical Pharmaceuticals Biotechnology and Pharmaceuticals Drug Manufacturing & Research Healthcare
Specialties
pharmaceutical
Business Classifications
B2C E-Commerce
About the Role
The Company is seeking an Executive Director for Global GMP Auditing. This pivotal role involves leading a global team of GxP auditing experts to ensure that the company's manufacturing sites, contractors, and suppliers meet the highest quality and compliance standards. The successful candidate will be responsible for developing and maintaining global Quality Management System documents related to auditing and inspections, as well as creating and adhering to a risk-based audit schedule. The role also includes evaluating audit findings, identifying and escalating compliance gaps, and providing training to auditors to enhance their skills in detecting and communicating GxP compliance concerns. The Executive Director will be expected to have a strong technical background, expert knowledge of GMPs and regulatory requirements, and the ability to lead high-risk or complex audits.
Candidates for this position at The Company should have a B.S., M.S., or Ph.D. in a relevant scientific discipline and a minimum of 10 years' experience in a GMP regulated environment, with a preference for those with a background in data analytics, vaccines, or biologics. The role requires a leader who is accountable, results-driven, and able to make independent and timely decisions. The ideal candidate will have a proven track record of effective communication, influence, and the ability to work with diverse teams. Experience in a health authority or regulatory role is a plus. The Executive Director will be expected to stay abreast of emerging regulatory trends and ensure the company's ongoing compliance with these requirements.
Hiring Manager Title Head of Global Quality Compliance Support
Travel Percent 30%
Functions
Finance Non-Profit Management
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Location:
Rahway, NJ, United States
Category:
Pharmaceuticals

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