Merck Associate Director, Global Development Quality, Drug Product Disposition in Rahway, New Jersey

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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Associate Director, SMDQ Rahway Drug Product Disposition reports to the Associate Director, GDQ Rahway Drug Product Disposition and supports development quality activities at the Rahway site or at other sites, specifically thorught the release of investigational medicinal products .

Primary responsibilities are:

The successful candidate will have leadership level accountability for a wide rage of activities including drug product batch disposition and related duties under GMP, ensuring a compliant clinical drug product supply. The role is responsible for a wide range of activities including leadership role of Global Development Quality initiatives which may span multiple sites and/or departments. Activities will cross manufacturing, testing and release as well as maintenance of permanent inspection readiness and regulatory inspection support. The candidate must have demonstrated skills for investigations including root cause analysis and effective corrective action/preventative action, demonstrated results and resolution of complex problems.

Responsibilities include, but are not limited to:

  1. Apply expert guidance and interpretation of Good Manufacturing Practice (GMP) and related regulatory requirements, standards, and guidance documents.

  2. Responsible and accountable for batch disposition activities for raw materials, excipients, components, and drug product.

  3. Audit batch records and related document types such as method validation, method transfer, stability data or reports. Make batch release or reject decisions.

  4. Provide quality oversight for resolution of complex investigations and non-conformances including Root Cause Analysis and Corrective Actions/Preventative Actions in accordance with GMP requirements and procedures.

  5. Support significant quality events such as Clinical Quarantine and Recovery actions requiring leadership of cross-functional teams, expedited action and decision making, and effective communication at all levels in the organization.

  6. Participate in quality alerts or Clinical Quality Management Systems changes as needed to meet GMP requirements.

  7. Lead, participate, collaborate in cross functional projects to develop effective processes or solutions.

  8. Support internal GMP quality audits, Health Authority, and/or Divisional audits and conduct walkthroughs according to procedure. Uphold GMP quality standards and meet required timelines.

  9. Author, review, and/or approve standard operating procedures within Global Development Quality and for or with functional areas.

  10. Proactively identify, develop, and implement work process improvements for efficiency and effectiveness.

  11. Perform all other quality review or oversight tasks and projects as assigned or delegated.

  12. Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

Education Minimum Requirement:

Bachelor degree in a Science or Engineering discipline (chemistry, biology, biochemistry, microbiology, engineering)

Required Experience and Skills:

  • Minimum of eight (8) years of experience in pharmaceutical industry or equivalent industry.

  • Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, clinical development, supply chain, engineering.

  • Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise including EU requirements, and application to R&D environment.

  • Strong leadership and communication skills, including written, oral and presentation skills.

  • Ability to work in high impact, visible position to deliver results and make sound decisions.

  • Ability to work across functions and sites, with all levels of staff and management.

  • Ability to work in dynamic R&D environment with rapidly changing needs.

  • Ability and willingness for occasional travel to other Merck R&D sites in the USA.

Preferred Experience and Skills:

  • Strong knowledge of drug product R&D or clinical supply functions and processes.

  • Knowledge and competency in CSTS, ERP, Trackwise, MS Office

  • Regulatory or QP inspections

  • Analytical and problem solving skills including experience in Lean Six-Sigma and Project Management

  • Track record for recognizing improvement opportunities, developing and implementing solutions creating measurable results.

  • Superior skills in collaboration, teamwork, conflict management.

  • Excellent verbal and written communication skills.

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.

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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.

Title: Associate Director, Global Development Quality, Drug Product Disposition

Primary Location: NA-US-NJ-Rahway

Requisition ID: QUA007560