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Sr. Specialist, Quality Systems Improvement Plan (QSIP) Facilitator

Requisition ID: QUA007980
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 Elkton site QSIP Facilitator will be a member of the site's Quality System Improvement Plan (QSIP) deployment team to transition the legacy Quality Management System to the new Quality Management System in accordance with initiatives driven by the Divisional QSIP project. This role will require working cross functionally and collaborating 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.

  • Maintains an active dialog and communicates between affected departments and leadership to ensure project progress and milestone success, escalate issues, identify and mitigate risks and celebrate successes.

  • Serves as the primary point of contact for workstream.

  • Ensures site representation in topic development. 

  • Responsible for communication and deployment of Divisional Quality System enhancements at the site level.

  • Responsible for change management including communications, sponsorship, and culture associated with site QSIP program. .

  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the site.

  • Analyzes and solves problems using standard problem solving processes and ensures procedures deployed are usable and efficient for site users.



Qualifications
Education Minimum Requirement:

  • Bachelor's degree in Science, Engineering, or related areas of study


Required Experience and Skills:

  • A minimum of 5 years of pharmaceutical manufacturing/laboratory experience including a minimum of 4 years in GMP environment

  • Understanding of FDA regulations/guidance and other major health authorities (EMA, ANVISA, etc).

  • Experience with Quality Systems enhancement and improvement

  • Experience leading teams in a matrix environment

  • Effective global communication skills (both written and oral)


Preferred Experience and Skills:

  • Laboratory experience with analytical method transfers, analytical method changes, and various laboratory systems

  • Project management experience

  • Strong analytical and problem solving skills

  • Change management experience

  • Ability to multitask and manage/prioritize multiple projects and deadlines

  • Strong customer service focus





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.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, 


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: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck

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