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Executive Director, Quality Operations Architect

Requisition ID: PRO018040

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.

Merck Manufacturing Division is seeking to modernize and implement state of the art manufacturing capabilities to ensure rapid delivery of safe, effective and cost effective medicines for patients globally. To enable this, the Manufacturing Systems, Design, and Commercialization Operating Unit is enrolling domain SMEs across the operating paradigm to identify and implement blueprints that codify design and operating principles that will deliver best in class manufacturing facilities and performance. It is expected that these design and operating principles will be derived from within and beyond the biopharmaceutical industry. Successful delivery of these blueprints will ensure new MMD facilities deliver the promise of the innovative medicines that they produce in a safe, compliant, expeditious and cost effective way.

The Quality Operations Lead Architect will be accountable for identifying, developing and ultimately implementing these best and next practices within the Quality Operations environment inclusive of Quality Control laboratories, Quality Assurance, and Global Compliance elements. Additionally, this leader will be part of the MSDC Architecture leadership team and accountable for close collaboration with other domain based Architects to ensure a seamless and integrated set of design and operating principles and blueprints are delivered to the manufacturing Operating Units in a way that delivers right the first time, high quality and efficient facilities and operations.

The scope of these operations is across Merck's large molecule portfolio (biologics and vaccines) and is inclusive of drug substance and drug product operations. Broad understanding of these operations and the associated business outcomes necessary to influence design and operating principles is a critical component of this role.

  • The incumbent will be accountable for identification, development and deployment of best and next practices within the Quality Operations envelope.
  • Comprehensive understanding of global regulatory requirements within the biopharmaceutical facility and deep knowledge of commercial cGMP requirements is a requisite.
  • Closely interacts internally with other departments principally, GBSO and GVO operations, Global Quality and externally within the biopharmaceutical sector to identify and secure best practices.
  • Prospect adjacent industries beyond the biopharmaceutical sector to identify and secure next practices to improve Quality Operations within MMD
  • Accountable for developing clear business cases, and where appropriate conducting pilots, to ensure emerging best and next practices will return meaningful value upon implementation.
  • Works in close collaboration with colleagues within the Architect function to set and drive an integrated strategy focused on delivering blueprints that will deliver improved business performance across architect domains.
  • Partners with new facility and new product introduction teams to ensure proper translation, implementation, and continuous improvement loop is created for blueprint execution.
  • Curation and prioritization of initiatives to drive improved Production Operations blueprints
  • Consistently demonstrate key leadership attributes within and beyond immediate responsibilities is essential:
    • Innovation - create opportunity and unlock innovation by balancing expertise with curiosity and a learning mindset
    • Leverage Tensions - embrace opposing forces to make timely and courageous trade-off decisions that enable short and long term value
    • Boundaryless Execution - build partnerships, break down barriers, and leverage networks across the ecosystem to create value
  • A track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
  • Demonstrated ability to work in customer facing environment, to effectively communicate and influence all levels of management, to translate innovation into business outcomes, and to challenge the status quo and take calculated risks

Education Requirement:
  • Required: B.S. in Scientific or Engineering discipline
  • Preferred: Advanced degree

  • 15+ years in the biopharmaceutical industry with a minimum of 10 years in a cGMP Quality environment within vaccines and/or biologics.
  • Strong financial acumen
  • Excellent written and oral communications skills
  • Ability to manage multiple projects and create a high performance work environment
  • Strong collaboration skills
  • Ability to work strategically as well as in a detail-oriented framework with all levels of management.

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

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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.

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


Job: Process Engineering
Other Locations: NJ, US; Boston, MA, US; PA, US
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

Nearest Major Market: Philadelphia

Executive Director, Quality Operations Architect

West Point, NY
Full Time

Published on 03/05/2019