Associate Director, Global Auditing Processes & Systems Analytics:
Merck USA

Merck USA
West Point Pennsylvania
Requisition ID: QUA006880

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, Business Processes and Systems is responsible for maintaining GMP auditing business processes and systems, including developing and reporting reliable auditing metrics. The Associate Director will support and lead continuous improvement projects as determined by the Director to help advance the auditing organization toward improved efficiency, data integrity, etc. This includes all supporting business processes and IT systems for auditing (End to End). The position will enable the Auditing organization to meet its business objectives and goals. 

The position will be responsible for developing, monitoring, trending, and reporting audit related data to understand and communicate the health of the Auditing QMS and the larger organization. The Associate Director must be capable of working independently with limited supervision in a virtual-management environment. 

The Associate Director will report to the Global Businesses and Systems Lead and will collaborate with Global and Site Auditors and other relevant Merck customers to meet customer demands and advance auditing business processes.

Primary Activities:

  • Extract auditing data and provide independent data analysis, including identification and interpretation of trends.
  • Communicate outcome of analysis to relevant customer groups at Merck to help drive improvements
  • Provide Business System Administrator support for 4 systems: ESAM (Trackwise instance to be retired), QCTS (Trackwise application for Merck Site Audit Reports), QSAT (New Supplier Trackwise Database), eSTARS (Legacy Supplier Oracle Database), BI Cognos Tool (Tool to extract data from eSTARS), Data Interface (IT tool used to transfer data from ST to ESAM/QSAT)
  • Coordinate training and assign individual user access privileges in the systems as needed (AMS will execute IT functions for providing access) and maintain approved user access forms
  • Responsible for maintaining system use and administrator procedures and custodial tasks for data, including answering questions regarding data
  • Manage system events/issues that may come up
  • Responsible for entering all system IT Tickets/help cases and managing them through completion 
  • Responsible for SOPs (User, System Administration, etc.) 
  • Ability to operate effectively in a complex business environment; changing priorities, significant regulatory complexity, multiple technology platforms, etc. 
  • Serve as Auditing Knowledge Network Steward and/or support Steward in maintaining content on the Community
  • Develop and Maintain scheduling for Global audits to maximize effectiveness, and efficiency
  • Responsible for updating audit team site and ensuring content is current and relevant
  • Assist Auditors and sites with Regulatory Agency requests related to audits



  • BS degree required, concentrations in Science or Engineering (chemical or mechanical engineering, pharmacy/pharmaceutics, chemistry, biology) is required. 


  • Minimum 10 years applied professional work experience working in one or more of the following areas: auditing, IT systems, manufacturing operations, quality organization, supply chain, technical operations, process research or development environment.
  • Prior experience in a Quality organization and prior experience working as part of a global program.
  • Strong skills in data analytics and reporting
  • Must be a change agent and be able to adapt in a dynamic environment.
  • Prior experience as part of cross functional teams, comfortable with speaking up and having diversity of thought.
  • Solid understanding of Quality activities, including Auditing.
  • Working knowledge of auditing principles and the understanding of the roles and responsibility of the related function.
  • Strong risk based decision making knowledge and skills
  • Strong collaborative and communication skills within teams and across Merck. 
  • Strong organizational and time management skills and demonstrated ability to independently manage multiple priorities, deal with ambiguity, changing priorities, aggressive deadlines, and ensure timely completion of deliverables. A high degree of resiliency is required for this position.
  • Strong work ethic
  • Demonstrated strong teamwork skills. 
  • Solid understanding of Merck’s Quality and Health Authority regulatory requirements.

  • MPS experience preferred 
  • Global work experience preferred

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: Qual Assurance & Ops Generic
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