Site Quality Management System Lead job in Wilson
|Employer:|| Merck & Co.|
|State:||North Carolina (NC)|
Requisition ID: QUA007625|
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.
Reporting to Excecutive Director of Wilson Site Quality Operations, is responsible for compliance and governance associated with but not limited to the Quality Management System (QMS), QMS system ownership, and the Quality and Compliance Excellence (QCE) programs.
• Sets compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements. Ensures new and updated divisional policies, guidelines and procedures are reviewed by system owners/SMEs for alignment to site procedures.
• Manages the QMS system ownership program for the site, including system owner and periodic system reviews training.
• Coordinates Quality Council (QC) meetings for the site and ensures alignment with QC requiements. Responsible for the development and issuance of pre-meeting and post-meeting deliverables (i.e., agenda, meeting minutes, actions, communications, etc.)
• Develops and facilitates compliance initiatives to improve compliance status and overall operational efficiency of the site.
• Sets direction for plantwide GMP and site initiatives involving participates from cross functional groups.
• Manages site readiness activities for regulatory inspections, including the desk audit requests in support of GMP certificate renewals. Leads compilation of agency responses and tracks of any remediation to closure.
• Provides Quality Assurance review and approval of GMP-related SOPs
Education Minimum Requirement:
• B.A. or B.S. degree required, preferably in science or engineering with a minimum of 6 years of pharmaceutical industry experience required.
Required Experience and Skills**:
• Working knowledge of Quality Management Systems and experience with multiple site Quality Systems
• Ability to provide quality compliance direction to all levels of personnel
• Meeting management and facilitation
• Organizational and time management
• Strong project management skills (e.g. resource estimation, issue escalation, updates)
Preferred Experience and Skills:
• Management of multiple tasks/priorities/actions and the timely completion of deliverables
• Ability to collaborate with various functional groups
• Ability to execute training to cross functional groups
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.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org .
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name: Merck