Associate Director, Regulatory Compliance
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director, Regulatory Compliance, is responsible for the coordination of divisional audits and regulatory inspections, support of validation activities, product protocol submission for export of product internationally, review of regulatory submissions, support of Operational Excellence Initiatives, Document Control program, ownership of the Change Control System, owner of Annual Product Review, Quality Risk Management Program, and other functions supporting the facility. The role is a managerial position and the responsibility includes direct supervision of staff to ensure global and site policies and procedures are adhered to governing these functions.
The Associate Director will be responsible for comprehensive management of all activities required to successfully support site regulatory compliance including the following:
- Ownership of the change control program in accordance with regulatory and internal Merck guidance
- Oversight of Quality Risk Management program.
- Perform yearly Annual Product Review.
- SOP development and approval as owner of the document control system.
- Direct support of regulatory inspections and audits.
- Direct support of validation activities and all other associated Quality functions.
- Perform product protocol submission for export of product internationally
- Responsible for monthly quality council meeting and reporting of metrics
- Bachelor’s or Master's Degree in Biology, Biochemistry, Chemistry, Engineering or other relevant discipline
- Minimum of 6 years experience in pharmaceutical operations, technical services, and/or quality operations within GMP environment. Minimum of 2 years managerial experience
- Regulatory Compliance, Quality Assurance experience in pharmaceutical industry
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Regulatory Compliance
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck