Merck Director, QMS Chapter 4 Owner – Product Development in Kenilworth, 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 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.

This position is critical in Merck’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.

Act as a cross-functional leader to Simplify, Standardize & Sustain our QMS, for now and the future. This Director will ensure cross functional alignment and act as change agent for the chapter, including Merck culture and behavior.

Lead development and execution of significant innovation projects driving operational improvements related to all the topics in Chapter 4. Hold the overall responsibility for Quality Management System Chapter 4 – Product Development that is critical to ensure the effective

governance and Quality requirements for GMP/GDP related activities across MMD and MRL. Lead the re-design, implementation and

sustainment of the global processes and systems that supports GMP/GDP related activities in the product development space end-to-end, specifically:

  • Leads a team of functional SMEs who own each topic in the Chapter

  • Manages the interdependency and collision among the topics within the chapter and between chapters

  • Develops and implements the chapter and supporting systems strategy to ensure sustainable compliance

  • Provides leadership and technical direction on regulatory product development requirements in the GMP/GDP environment

  • Ensures quality requirements are sound and compliant by using insights, experience and judgment t o proactively drive and improve the company’s QMS

  • Helps maintain and further strengthen cross-divisional alignment and collaboration where processes and supporting systems span across MRL and MMD

Education Minimum Requirement:

  • Postgraduate/Advanced (M.S, etc.) degree in Life Sciences, Engineering or related relevant discipline

Required Experience and Skills:

  • Thorough understanding of regulatory requirements of product development for drugs, devices, biologics, including quality risk management and knowledge management.

  • Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in leading Product Development functions; experience in vaccines, biologics, devices and API regulations preferred.

  • Ability to accurately interpret and apply regulatory expectations for product development in a drug, device and biologics manufacturing environment.

  • Strong project management skills.

  • Capable of working and communicating effectively with all levels of the organization globally.

  • Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.

  • Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance.

  • Proven ability to effectively drive change across the network major organizations or organizational units.

  • Self-motivated with a high degree of ownership and accountability for results.

Preferred Experience and Skills:

  • Experience leading Product Development functions; specifically in vaccines, biologics, devices and/or active pharmaceutical ingredients (API).

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 an accommodation for the application process please email us at staffingaadar@merck.com.

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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 its manifestations.

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

Other Locations: NA-US-Pennsylvania, NA-United States, NA-US-NJ-Kenilworth, NA-US-New Jersey, NA-US-NJ-Rahway

Title: Director, QMS Chapter 4 Owner – Product Development

Primary Location: NA-US-PA-West Point

Requisition ID: REG003049