Associate Director, QSIP Site Lead:
Merck USA

Merck USA
Elkton Virginia
Requisition ID: QUA006997

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 Elkton site QSIP Lead will lead the site’s Quality System Improvement Plan (QSIP) deployment team to transition the legacy Quality Management System to the new Quality Management System in accordance with initiatives driven by the Divisional QSIP project. This role will require working cross functionally with Operations, Technology, Supply Chain, and Quality on both the global and local level. The QSIP Lead is knowledgeable in Federal and other regulatory agency requirements, cGMPs, and Merck Guidelines and Sterile Standards. He/She will be responsible for ensuring the team remains in an inspection ready state for regulatory agencies.

Primary Roles include, but are not limited to:

  • Manages a team of 4-5 personnel deploying the site QSIP program.
  • Maintains an active dialog and communicates between affected departments and leadership to ensure project progress and milestone success, escalate issues, identify and mitigate risks and celebrate successes.
  • Serves as the primary point of contact for all above site teams for QSIP.
  • Ensures site representation in topic development. 
  • Responsible for communication and deployment of Divisional Quality System enhancements at the site level.
  • Responsible for change management including communications, sponsorship, and culture associated with site QSIP program. .
  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the site.
  • Analyzes and solves problems using standard problem solving processes and ensures procedures deployed are usable and efficient for site users.
  • Works in an empowered, self- directed culture.


Minimum Requirements:

  • B.S., B.A. degree in Science, Engineering, or Business
  • A minimum of 7 years in a GMP environment with 4 years leadership experience
  • Experience with Quality Systems enhancement and improvement
  • Project management experience
  • Experience leading teams in a matrix environment
  • Change management experience
  • Strong working 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 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, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications