Quality Process Improvement Topic Lead:
Merck USA

Merck USA
Durham North Carolina
Requisition ID: QUA006862

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 Associate Director, QSIP Project Management, the Sr. Specialist, QSIP, has primary responsibility for specific project work regarding maintaining compliance to Divisional and Regulatory standards and requirements. As an integral member of the site Quality System Improvement Plan (QSIP) deployment team, the successful candidate will represent the site to Divisional QSIP project teams and will build and/or improve the site-wide Quality Management programs 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.

Primary Roles include, but are not limited to:

  • Works in an empowered, self- directed culture with a moderate level of guidance and direction.
  • Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.
  • Represents site interests on network Quality System project teams.
  • Responsible for communication and deployment of Divisional Quality System enhancements at the site level.
  • Responsible for developing and deploying site-base training to personnel impacted by Quality System enhancement initiatives.
  • Develops/maintains site procedures and reviews updates to divisional guidelines.
  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
  • Represents site interests on network Quality System project teams.
  • Analyzes and solves problems using standard problem solving processes.

The Sr. Specialist, QSIP, will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:

  • Active member of the Divisional Quality System Improvement Plan (QSIP) project(s).
  • Site representative / primary point of contact under the direction of the Associate Director or Director for Quality System enhancements
  • Responsible for Quality System enhancement identification, development, and deployment at the site level in alignment with Divisional Quality System project team initiatives.
  • Responsible for coordinating actions across impacted teams to ensure flawless deployment of Quality System enhancements. 
  • Reviews, revises and approves SOPs as appropriate
  • Performs special quality projects / investigations as requested by Senior Quality Management.
  • Other duties as requested by Quality management.


B.S., B.A. degree in Science, Engineering, Business or Humanities


  • A minimum of 7 years of leadership experience including a minimum of 4 years in GMP environment
  • Understanding of FDA regulations/guidance 
  • Experience with Quality Systems enhancement and improvement
  • Project management experience
  • Strong working knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry
  • Experience leading teams in a matrix environment
  • 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

  • Pharmaceutical manufacturing background with strong knowledge of manufacturing processes and support systems
  • Lean Six Sigma certification
  • Experience with global projects

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.


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


            EEOC Poster

            EEOC GINA Supplement 

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