Associate Director, Quality Systems:
Merck USA

Merck USA
Durham North Carolina
Requisition ID: QUA006947

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 the Site Director Quality Systems and Compliance, the Associate Director – Deviation Management position will provide leadership, focus and governance to the site deviation management program that supports the Durham Vaccine Manufacturing Facility. The incumbent will lead a team responsible for instituting consistent practices across the Durham Facility in the disciplines of deviation management, corrective and preventive actions (CAPA), and customer complaints. The incumbent will provide governance and leadership for all activities related with the Deviation, CAPA and Complaint Management programs. The successful candidate will build and/or improve the site-wide management programs by defining requirements established via in depth review of existing systems, in concert with strategic direction facilitated by our global business model and regulatory compliance. The role will require working with Operations, Technology, Supply Chain, and Quality on both the global and local level. As a sub-system owner of Deviation Management, CAPAs and Complaints for the site, the incumbent will also be responsible for the development of metrics, ensuring consistency across the site, and presenting the system during audits and inspections.

Primary Roles include, but are not limited to:

  • Provide management and leadership for the Deviation Management group.
  • Ensure compliance with all global and regulatory standards
  • Provide guidance to staff for the evaluation of existing deviation, CAPA and complaint systems on the global and local level.
  • Develop and report to senior site leadership data analysis and metrics to ensure quality of the Deviation Management, CAPA, and Complaint System programs.
  • Develop and action metrics for tracking and monitoring Quality Management Systems under area of responsibility. Perform quality checks to ensure accuracy, completeness and proper usage of data.
  • Prepare and/or review activity, progress, and performance metrics reports.
  • Serve as a sub-system owner for the Durham site for the Deviation Management System, CAPA Management System and the Compliant Management System.
  • Prepare and/or review activity, progress, and performance metrics reports.
  • Responsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous improvement.
  • Serves as Subject Matter Expert (SME) for areas of responsibility.
  • Direct support of regulatory inspections and audits.


Minimum Requirements: 

  • BS or BA degree in Engineering or Science 
  • Minimum of Eight (8) years experience in the Pharmaceutical industry with significant experience in biologics, vaccines and/or biopharmaceuticals compliance
  • Minimum Five (5) years of leading/managing experience 
  • Understanding of FDA regulations and cGMPs with experience in deviation management, CAPAs, complaints, compliance issues, inspection trends, industry quality assurance practices and systems, and personnel management skills in a highly regulated industry
  • 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, and 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 innovative mindset
  • Demonstrated cross cultural agility and resourcefulness 
  • Must possess working knowledge of Microsoft Office Suite
  • Experience with Trackwise and SAP
  • Lean 6 Sigma methodologies
  • Demonstrated Technical and / or Manufacturing experience

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 [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.


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Job: Quality Operations
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