Senior Specialist, Vendor Qualifications:

Upper Gwynedd Pennsylvania
Requisition ID: CLI007030

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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

Primary activities include, but are not limited to:

  • Assess qualification scope and assemble team of qualified subject matter experts (SMEs).  Gather qualification information from Vendor and distribute to SMEs to assess go/no go decision and formulate qualification strategy if appropriate.  
  • Lead qualification.  Gather report sections, recommendations for improvement and mandatory actions, if any, from the SMEs and complete the Qualification Report. Issue final Qualification Report and update Vendor qualification status in the system.  Send recommendations and/or mandatory actions to Vendor and follow up until all recommendations have been reviewed and approved and all mandatory actions have been closed by the SMEs.  
  • Track, and manage vendor qualifications and associated deliverables.  Upload all required documentation into the document repository.  Post final Qualification Report to intranet site.  Support Business Area reconciliation activities for TMF.  Support internal Business Area QA audits. 
  • As appropriate, provide assistance with vendor performance management/metrics and participate in initiatives to improve procedures and systems related to Portfolio Sourcing & Relationship Management.  This includes interactions with internal stakeholders and external vendors, knowledge and application of sourcing strategy. 


  • Minimum 4 year degree or ex-US equivalent from an accredited university in Business, Technical, or Life Sciences.  


  • Proven ability to successfully lead cross-functional teams.  Strong organizational, interpersonal, and communication skills.  Excellent decision and problem solving skills.  Takes initiative in solving problems and demonstrates self-reliance and resourcefulness.  Able to handle projects independently with minimal supervision.  Good computer skills along with knowledge of Word, Excel and PowerPoint.


  • Experience in qualifying/auditing vendors providing services for clinical studies.  5 years experience in the pharmaceutical industry.

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. 


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Job: Clinical Research 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