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Environmental Monitoring Quality Lead

Requisition ID: QUA007959

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 Quality Environmental Monitoring (EM) Lead will provide management of the End to End (E2E) Live Virus Vaccine (LVV) EM team, the EM program for Operations of LVV products, regulatory inspection support, and initiation of sterility assurance initiatives at the site. The individual in this role is a member of the E2E Quality leadership team, the EM Center of Excellence (CoE), and additional site leadership teams. This role will be responsible to drive LVV E2E compliance to critical EM business processes/systems and critical programs designed to heighten our contamination control through the use of Lean Manufacturing/Six Sigma, inclusion behaviors, and Change Execution Management.
Primary activities:

  • Manage a team of 5-10 EM specialists executing tactical and strategic EM objectives for LVV E2E Operations. Develop a high performing team through real time coaching; ensure each team member has a meaningful and up to date personal development plan.
  • Work cross-functionally with Operations, Technology, and Quality to identify and remediate EM issues within the LVV E2E and West Point site identified during self-audits, regulatory inspections, process deviations, Quality Manual Gap assessments, or as part of continuous improvement. 
  • Act with a high degree of autonomy as the LVV E2E subject matter empowered to make decisions and recommendations on behalf of the LVV E2E on matters relating to Merck’s EM procedures and policies.
  • Manage emerging EM issues for the LVV E2E or West Point site, present to regulatory authorities and Senior Site Leadership, and represent Merck in external associations. 

Qualifications

Education Minimum Requirement:

  • Bachelor’s degree in science, engineering, or related areas of study.

Required Experience and Skills:
  • At least 5 years of work experience in the pharmaceutical industry
  • Prior people management experience.
  • Demonstrated strong problem identification and solving skills
  • Aseptic processing/sterility assurance experience


 

Preferred Experience and Skills:

  • Experience with Lean Manufacturing/Six Sigma, talent development, domestic/international regulatory agencies, project management, and change execution management
  • Sterile operations experience in manufacturing sterile biologic or pharmaceutical product
  • High technical aptitude and experience in the design, development, implementation and sustainment of an Environmental Monitoring and Cleanroom Conduct program


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 

          OFCCP EEO Supplement

 Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.

Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck
Company
Merck
Posted
09/06/2018
Type
Full time
Location
West Point, PA 19486, US