Senior Quality Specialist 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.
I. GENERAL SUMMARY:
The Sr. Specialist, Vendor and Change Management is accountable for maintaining regulatory compliance for the change management systems at Merck’s Durham, NC Vaccine manufacturing facility. The incumbent will be part of a site-wide team providing Quality oversight of all change management and vendor management systems. The role will require working closely with Quality, Technical, Regulatory CMC, Vendors and IT organizations at the global and local level.
II. GENERAL PROFILE:
• Works in an empowered, self directed culture with a great deal of independent decision making in the planning, coordination, and execution of multiple independent projects.
• Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.
• Responsible for effective change request and vendor document review to ensure conformance to Merck.Manufacturing Standards, MMD Quality Policies, cGMPs for the execution of change requests, development of Quality Technical Agreements.
• Responsible for supporting supplier audits.
• Trains site system users to function as Quality, Technical, Operations, Change Owners within the change management system.
• Develops/maintains site procedures and reviews updates to divisional guidelines.
• 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.
III. BUSINESS EXPERTISE:
• Understands the fundamental business drivers for the company; uses this knowledge in own work
• Understands and applies regulatory / compliance requirements relative to their role
IV. FUNCTIONAL EXPERTISE:
The Sr. Specialist, Change Management will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:
• Providing Quality oversight of all change-related activities so that they can be completed on schedule and in compliance with local procedures and industry standards.
• Development and maintenance of robust site-wide systems to manage change-related activities.
• Review and approval of change request and compliance documents supporting GxP systems and manufacturing processes including, but not limited to, change control documentation, vendor change notifications, Quality Agreements, and deviations.
• Manages review and implementation of Vendor Change Notifications.
• Functions as system steward for the following systems: Global Change Management-Trackwise, Supplier Transparency.
• Represents site at global level for change management and supplier management.
• Reviews and approves SOPs as appropriate.
• Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate
• Performs special quality projects / investigations as requested by Senior Quality Management.
• Other duties as requested by Quality management.
V. INFLUENCE / DECISION MAKING / PROBLEM SOLVING:
• This position has an influence on the continuous improvement of existing and new products at the Durham site through support of efficient, effective change management and supplier management systems that lead to the expansion of the Durham product portfolio.
• The individual in this role is required to make real time decisions in a time constrained environment.
• This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities.
Education Minimum Requirement:
• Bachelor Science in Science, Engineering, or Business
Required Experience and Skills:
• B.S., B.A., or M.S. degree in Science, Engineering, or Business or equivalent experience
• Minimum seven (7) years experience in Quality, Regulatory, Technical, or Manufacturing Operations.
• A minimum of four (4) years of experience in GMP Change Management or equivalent system in a regulated environment
• Understanding of FDA regulations/guidance as related to change management and supplier management
• Experience with Quality systems including change control, incident management, vendor management, and deviation management
• Project management experience
• Experience working with customers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships
Preferred Experience and Skills:
• Knowledge of the manufacturing processes and support systems across the Durham organization.
• 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 global communication skills (both written and oral)
• Ability to multitask and manage/prioritize multiple projects and deadlines
Strong customer service focus
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 an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck