Associate Director, Quality Assurance:
Merck

QUA006867-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: QUA006867

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. 


This position reports to the Director, Clinical Supplies Quality and is critical to maintaining the clinical supply chain via supporting disposition of investigational medicinal product in our clinical supplies inventory system. Specifically this includes ensuring our clinical supplies are in compliance with current Good Manufacturing Practices and relevant regulatory submissions via direct support for batch release and leading team-based process assessments and enhancements. Areas of focus of this position revolve around the detailed workings of clinical packaging and labelling activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex / niche supply chains and supply types to support aspects such as Managed Access Programmes, Joint Ventures / Collaborations, Independent Investigator-Initiated Studies etc. in addition to standard clinical protocols. Additional support is required from this role to be able to manage when necessary significant quality events such as formal Quarantine and Recovery actions that require rapid and effective liaison with many internal and external stakeholders, including at senior levels. 


Responsibilities include but are not limited to the following: 

  • Evaluation and/or disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations. 
  • Closely collaborate with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place. 
  • Coordinate and provide guidance in the preparation of procedures, processes and quality improvements where warranted. 
  • Lead the coordination of significant quality events including fact finding, investigation support, coordination of clinical quarantine and recovery actions. 

Qualifications

Education: 

  • Bachelor’s Degree, Scientific Discipline Major 

Required: 

  • Minimum of 8 years’ experience in the Pharmaceutical or equivalent industry

Preferred: 

  • Strong understanding of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying cGMPs to R&D environment 
  • Computer skills; knowledge and competency in ERP/MES, Trackwise, PowerPoint, Excel and Word 
  • Ability to independently manage multiple priorities and projects 
  • Comprehensive Lean Six Sigma and Project Management skills; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation 
  • Strongly developed cross-functional teamwork, collaboration, influencing and negotiating skills 
  • Ability to lead teams of a cross-functional and multi-level nature, including senior management representatives 
  • Excellent verbal and written communication and presentation skills. 

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 staffingaadar@merck.com.

  

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.


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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Quality Assurance
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Employee Status: Regular
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Company Trade Name: Merck
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