Change Control Process Steward Job
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 Senior Specialist Change Management is accountable for maintaining regulatory compliance for the change management systems at Merck’s Elkton, VA. manufacturing facility. The incumbent will be part of a site-wide compliance team and be the subject matter expert the change management system. The role will require working closely with Quality, Technical, Regulatory CMC, Vendors and IT organizations at the global and local level.
• Works in an empowered, self directed culture with a great deal of independent decision making in the planning, coordination, and execution of the change control system.
•Subject matter expert for Change Management Program at the site.
• Development and maintenance of robust site-wide systems to manage change-related activities.
•Interfaces with regulatory agencies about Change Management program.
•Maintaining an active dialog and communicating between affected departments and leadership to ensure effective change management and awareness related to the program.
• Responsible for effective change management document review to ensure conformance to Merck.Manufacturing Standards, MMD Quality Policies, cGMPs for the execution of change requests.
• Trains site system users to function as Quality, Technical, Operations, Change Owners within the change management system.
• Functions as system steward for the following systems: Global Change Management-Trackwise
• Develops/maintains site procedures and reviews updates to divisional guidelines.
• Represents site at global level for change management, works with global team to ensure guidelines are developed with a site perspective and to ensure site alignment with other sites on standard practice.
• Analyzes and solves problems using standard problem solving processes.
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
• Understands the fundamental business drivers for the company; uses this knowledge in own work
• Understands and applies regulatory / compliance requirements relative to their role
• Reviews and approves SOPs as appropriate.
• Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate
• Other duties as requested by Quality management.
• This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities.
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.
Education Minimum Requirement:
- Bachelor Science in Science, Engineering, or Business
Required Experience and Skills:
• B.S. or B.A. degree in Science, Engineering, or Business or equivalent experience
• Minimum five (5) years experience in GMP Quality, Regulatory, Technical, or Manufacturing Operations.
• A minimum of two (2) years of experience with GMP Change Management or equivalent system in a regulated environment • Experience with regulatory inspections
• Experience with Quality systems including change control, incident management, vendor management, or deviation management
• Experience working with customers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships
Preferred Experience and Skills:
• M.S. degree in Science, Engineering, or Business or equivalent experience
• Familiarity with the following systems Preferred: Trackwise, Supplier Transparency
• Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry.
• Strong analytical and problem solving skills
• Effective communication skills (both written and oral)
• Ability to multitask and manage/prioritize multiple projects and deadlines
•Strong customer service focus
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully:
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: Quality Operations
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck