Assoc. Director Change and Vendor Management, Quality:
Merck USA

Merck USA
Durham North Carolina
Requisition ID: QUA006519

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, Change and Vendor Management will provide leadership, focus and governance to the site change, vendor, and document control programs that support the Durham Vaccine Manufacturing Facility. The incumbent will lead a team responsible for instituting consistent practices across the Durham Facility in the disciplines of process/product change, equipment change, automation change, vendor management, document management and SOP management. The incumbent will provide governance and leadership for all activities related with the Change Management program in the Durham Center for Vaccine Management, while actively supporting, participating in and embracing an empowered team culture.

• Manages individual contributors (professional employees) and/or supervisors
• Contributes to the performance and results of the department
• Adapts departmental plans and priorities to address resource and operational challenges
• Decisions are guided by policies, procedures and business plan; receives guidance from manager
• Provides technical guidance to employees, colleagues or clients
• Anticipates and interprets client and/or customer needs to identify solutions

Applies management skills to align staff activities with department objectives

Specific to Change and Document Management, the Associate Director will be responsible for comprehensive management of all activities required to successfully support the site Change Management and Document Management programs to include the following:
• Provide management and leadership for the change control, vendor management, and document management groups.
• Ensure compliance with all global and regulatory standards
• Develop and report to senior leadership data analysis and metrics to ensure systems’ compliance and performance.
• Serve as a sub-system owner for the Durham site for the Change Management and Document Management Systems.
• Provide guidance to staff for the implementation, management and enhancement of document control systems on the global and local level and ensure consistent document management processes across all control documents.
• Represent Durham in above site Change Management, Document Control and SOP Management, and other related initiatives
• SOP development and/or approval.
• Direct support of regulatory inspections and audits.
• Direct support of validation activities and all other associated Quality functions.

• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

• Explains difficult concepts and persuades others to adopt point of view.
• Communicates information, asks questions and checks for understanding
• Accountable for the performance of work group
Decision Making
• Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives
• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

• Forecasts resource needs; manages allocated budget


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. 

Minimum Requirement: 

- BS degree in Engineering, Science or Business
- Minimum 8 years’ experience in the Pharmaceutical industry with significant experience in biologics, vaccines and/or biopharmaceuticals compliance
- A Minimum of 5 years of leading/managing experience
- Proven experience in Global Pharmaceutical Business - Working in Quality Assurance functions
- Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personnel management skills.
- Proven application of effective supervision principles
- Works independently with all levels of the organization, and has demonstrated the following skills: Rapid / Disciplined decisions, Acts with courage and candor 
- Drives results, Escalation of issues / concerns to management, as appropriate 
- Ability to Prioritize, Align and Simplify
- Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence and the ability to present to groups across the organization as needed.
- Knowledge of cGMPs, technical writing, data management collection and analysis 
- Demonstrated cross cultural agility and resourcefulness

Preferred Experience and Skills:
• Previous experience with electronic document management systems
• Advanced degree
• Demonstrated innovative mindset

- Lean Six Sigma Green Belt Certification


If you need an accommodation for the application process please email us at [email protected]


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.


For more information about personal rights under Equal Employment Opportunity, visit:


            EEOC Poster

            EEOC GINA Supplement 

Job: Quality GMP Related
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications