Associate Director, External Quality Significant Investigation Subject Matter Expert

  • Company: Merck
  • Location: West Point, Pennsylvania
  • Posted: November 09, 2016
  • Reference ID: QUA005188
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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The External Quality Assurance - Sterile organization is seeking an interested candidate to lead and oversee Significant Investigations, Fact Findings, and Recalls across the network. This person will be responsible for supporting timely and compliant execution of significant investigations in collaboration with external parties/partners and alliances (EP's) for manufacture, testing, packaging, storage, and distribution of sterile pharmaceutical products.

The candidate will work with individuals across the network to identify root cause, ensure sound investigation reports are authored, and proactively identify other sites/processes that could have similar issues so that corrective actions can be implemented. The candidate will need to successfully interface with and lead teams comprised of quality, technology, and manufacturing operations located at sterile manufacturing sites around the world. Onsite travel will be required.

The person will be responsible for ensuring that investigations are conducted and documented in conformance to all applicable regulatory requirements and Company policies and are able to withstand regulatory scrutiny. The candidate will exercise a leadership role in monitoring and maintaining the status and completion of Significant Investigations, Fact Findings, and Recalls across and other pertinent legal requirements. The candidate will be responsible for providing senior leaders with the current status and final outcome on a daily and weekly basis. The candidate will ensure continuous improvement of the problem solving process by conducting after action reviews.

Interested candidates must understand and be able to apply regulatory/compliance requirements relative to their role. The candidate must be able to demonstrate the ability to quickly solve technical challenges, to lead project teams, to appropriately apply project management and change execution management principles on complicated projects, and to successfully influence others outside their direct line of authority and in other organizations.

The candidate will act as a resource for External Site Quality Leads and Product Quality Managers who are the primary contacts with each external party/partner and promote teamwork and open discussion of issues, coaches and guides others internally and externally. The candidate must effectively communicate complex issues to all levels and works to build alignment around a complex situations.

Education Minimum Requirement:
  • BS or MS degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or other scientific field
Required Experience and Skills:
  • Minimum eight years experience in the pharmaceutical industry.
  • Minimum two years experience in conducting and authoring investigations in the pharmaceutical industry.
  • Sterile operations experience in manufacturing sterile biologic or pharmaceutical product
  • Experience in interacting with FDA and International regulatory authorities.
  • Must have the willingness to travel to manufacturing sites within the sterile network worldwide on a frequent basis as events warrant for on-site support.
Preferred Experience and Skills:
  • Conversant with all domestic and foreign regulations and compendia governing plant operations.
  • Strong project management skills & proven ability to lead and/or manage complex projects
  • Strong interpersonal and leadership skills to participate actively in virtual teams & communicate, collaborate, negotiate & persuade across a broad variety of functions and cultures and with internal and external stakeholders
  • In-depth working knowledge and application of GMPs/GLPs
  • Demonstrated self-starter with capability to develop innovative solutions to challenges
  • Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
  • Demonstrated personal networking and relationship building skills
  • Speaks with courage and candor; comfortable presenting to senior leadership
  • Strong written and verbal communication skills

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

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​

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