Associate Director, Operations MRLQA GLP:
Merck

QUA006799-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: QUA006799

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. 


Essential functions include but are not limited to:  working independently, across functional disciplines and QA leads, with guidance as needed, to plan  and execute operational activities to include inspection management strategy, global core activity, GLP Master Schedule, pre-clinical Due Diligence, SOPs, auditor training/up-skilling, QA oversight of global facility management supporting the GLP areas, and prepares metrics for monthly review with GLPQA for quarterly  compliance councils, dashboards and Board updates including monthly or other stakeholder forums.  


Contributes to complex projects within Merck Research Labs (MRL) QA GLP and across areas in MRL QA to achieve overall quality goals. Oversees, trains and obtains collaboration and help from QA professionals to execute and maintain the overall GLP QA strategic plan to ensure programs meet internal standards and regulatory requirements. Collaborates within MRLQA GLP, MRL QA Business Operations and with stakeholder areas to ensure achievement of quality goals and pre-clinical submission timelines. Assignments are of moderate complexity and require specific knowledge unique to the GLP and regulated in house laboratory  areas, specific functional area practices and SOPs, as well as a broad understanding of GLP stakeholder areas and MRL QA.


Primary activities include but are not limited to :

  1. Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience with guidance and support from the MRL QA GLP Leads and colleagues within and external to MRL QA, as needed.
  2. Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. 
  3. Responsible for practical knowledge of current and emerging global guidelines, regulations, relevant regulatory approaches, actions and status of industry standards to effectively contribute to develop and advance QA strategies . Includes regular Freedom Of Information communication & engagement with GLP QA and the Business.
  4. Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate. 
  5. Contribute to the Audit strategy and plan. Execute audit plan.  Responsible for global GLP QA team core activity schedule, communication and conformance.  Approx 25% audit support.
  6. May manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives. 
  7. Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Laboratory Practice, French GLPs, OECD guidelines), and company policies/procedures.  May assist with the preparation or review of relevant SOPs or policies relevant to MRL QA GLP or partnering within MRL QA. As a quality by design approach collaborates with GLP and regulated lab stakeholder areas for sop updates or new processes.
  8. Supports regulatory compliance in MRL QA GLP and MRLQA areas, as appropriate . 
  9. Collaborates effectively across global functional programs  within MRL QA GLP and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations.
  10. Develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding within MRL QA GLP and partnering MRL areas, where applicable.
  11. Responsible and/or contribute to OECD & FDA GLP and other relevant policy or guidance review. Maintain awareness of regulations, policy or guidance changes or planned updates.

Qualifications

Education:  

  • BS/BA degree in an appropriate science or equivalent field (e.g., Toxicology, Biology, Analytical Chemistry, etc.).

Required:  

  • Extensive experience in the applications of Good Laboratory Practices in Toxicology, Bioanalysis, Clinical Pathology, Pathology or Analytical Sciences.  
  • Minimum of six (6) years experience in the pharmaceutical industry, auditing or quality experience and a thorough understanding of GLPs and international guidelines are required. 
  • Possess extensive technical knowledge for all areas of GLP study conduct.  
  • 5 + years’ experience in working with and directly communicating with management with proven accountability, and  demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
  • Demonstrated teaching and coaching capabilities 
  • Proven ability to function autonomously at a manager level in a matrix model and in a team environment
  • Proven business management capability
  • Proven ability to think creatively and to develop and execute strategic plans

Preferred: 

  • Overall GLP pre-clinical study and support functions experience an asset. 
  • Experience in Bioanalysis.
  • Prior supervisory, integration due to in licensing or Due Diligence experience is an asset.
  • Experience as a manager of people or team leader


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:

 

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            EEOC GINA Supplement 



Job: Quality Assurance
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement