Merck Associate Director, Quality Assurance, BCR in West Point, Pennsylvania

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 Associate Director of Quality Assurance (QA) within the Biological Critical Reagents (BCR) Hubs is responsible for providing Quality direction and oversight to BCR Hubs in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of Site and MMD priorities. The Associate Director drives quality improvement activities and ensures alignment across Laboratory Operations in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems in Laboratory Operations in accordance with cGMPs, international regulations and Merck guidelines, policies and procedures.

The Associate Director will lead key compliance projects for the BCR Hubs aimed at elevating the compliance posture. As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines.

Education Minimum Requirement:

  • B.S. and/or M.S. in Biology, Molecular Biology, Biochemistry, or related biological science

Required Experience and Skills**:

  • Bachelor’s with at least 7 years of quality experience; Master’s with at least 5 years of quality experience

  • Supervisory experience, leadership, and teamwork skills

  • Ability to work independently as well as manage teams

  • Strong quality mind and technical knowledge

  • GMP experience

Preferred Experience and Skills:

  • Progressive and demonstrated Quality decision making responsibility

  • Project Management, Change Execution Management and Team Leadership experience in a Quality function.

  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

  • Demonstrated self-starter with capability to develop innovative solutions to challenges.

  • Demonstrated facilitative leadership skills and able to lead cross-functional project teams to deliver results.

  • Proven analytical aptitude, critical thinking skills and ability to apply key concepts.

  • Speaks with courage and candor.

  • Strong written and verbal communication skills.

  • In-depth working knowledge and application of GMPs / GLPs in biologics and/or vaccines

  • Proven ability to manage multiple projects simultaneously.

  • Experience in pharmaceutical laboratory operations or related environment.

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, visit:

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

Job Qual Assurance & Ops Generic

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

Other Locations: NA-US-PA-North Wales

Title: Associate Director, Quality Assurance, BCR

Primary Location: NA-US-PA-West Point

Requisition ID: QUA007467