Associate Director Biologics Quality Operations External Manufacturing

  • Company: Merck
  • Location: West Point, Pennsylvania
  • Posted: December 10, 2016
  • Reference ID: QUA005361
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.

This position Reports to the QO Director, Biologics External Manufacturing, for general advice and instruction concerning Quality Operations, but functions independently.

Job Purpose

Responsible for providing Quality Oversight of external parties, that manufactures biologics and vaccines on behalf of Merck. Ensures that all vaccine and biologic products manufactured at external partners and alliances are manufactured, packaged, analyzed, released, stored and distributed in accordance with Merck expectations and all applicable regulatory requirements.

Ensures the quality performance of external partners through direct oversight support and technical advice. This includes overseeing activities such as Partner Selection and GMP Due Diligence including establishing Quality Agreements; Quality Assurance including permanent audit readiness, complaint management, change control oversight, metric review, providing coaching and training etc.; Quality Control such as product release, atypical investigations and change control requests. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.

Remain informed of current GMP requirements and industry trends. Support review of regulatory filings, requests for information and subsequent supplemental packages. Advise support groups on aspects of GMP compliance. Support the development of GMP policies and procedures. Ensure all SOPs are aligned with current policies and applicable regulations. Build and maintain strong relationship with external parties. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities

  • Conducts quality due diligence assessments for pre-approval considerations of new external partners. Supports the partner in remediation of due diligence and/or pre-contract audit gaps. Assures the development and maintenance of a Quality Agreement with the external partner. Acts as the Quality expert on Merck behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the external partner on quality related terms.
  • Collaborates with the external partner to ensure that effective and robust Quality Systems and Quality management are in place. Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted. Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Stability and Product reviews.
  • Acts as the Merck Quality point of contact for technology transfers to the external partner and leads all quality aspects of the technology transfer.
  • Executes a program of calibrated Quality oversight based on the scope of operations, product type, capabilities and quality and compliance performance of the external partner.
  • Approves the release of vaccine and biologic products with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations.
  • Is responsible for defining Quality expectations on Process Change Requests (PCRs) submitted by the external partner and ensuring conformance to all PCR requirements prior to authorizing release of batches made under the changes; will ensure all validation expectations are met, where necessary, by on-site support for demonstration batches or validation batches.
  • Guides investigations conducted by the external partners' into abnormal operational occurrences such as batch rejections, atypical events, customer complaints etc. Coordinates support from appropriate staff groups and recommends corrective measures; assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls as needed.
  • May act as or support the regulatory compliance liaison on Merck behalf to interface with regulatory agencies.
  • Closely collaborates with appropriate business and operations areas to achieve Merck objectives.

Education Minimum Requirement:
  • Bachelor degree in Science Discipline (or equivalent).
Required Experience and Skills:
  • Minimum of 10 years' experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Preferred Experience and Skills:
  • Experience with biologic and/or vaccine quality assurance.
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
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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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