Merck Senior Specialist, Global QMS, Chapter 5-Technology Transfer and Commercialization 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.

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.

The Senior Specialist, Quality Management Systems, brings broad quality management expertise, operational excellence and expert project management skills to support the development and implementation of processes, procedures and corresponding controlled documentation and systems within QMS Chapter 5, Technology Transfer and Commercialization. The chapter encompasses requirements and processes for effective commercialization, transfer of technology and validation of pharmaceutical, biological and /or medical device products. This Senior Specialist will work closely with other QMS chapter representatives as part of the QMS Development & Deployment Support Network, and be a key contributor to advancing the MMD QMS redesign project.

In collaboration with QMS Chapter & Topic Owners, the Senior Specialist is also responsible for ensuring the end-to-end life cycle process for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.

• Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountabilities

• The Organization and Infrastructure to support the execution of the processes are defined and installed

• Metrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement

Primary Activities

Primary activities include, but are not limited to:

  1. Support the design, development and implementation of QMS projects within the Technology Transfer and Commercialization chapter, in close collaboration with topic leads and the QMS Chapter Owner.

  2. Act as a key topic development team member and subject matter expert (SME) for QMS by providing sound quality management and operational excellence input to assigned deliverables/topic development projects.

  3. Take the lead for managing QMS topic development projects in cross-functional global teams, including planning, management, scheduling, and deployment of project deliverables in line with business requirements, compliance and regulatory standards. Interface with other chapters/topics, and stakeholders across the network as required.

  4. Ensure proper project management, prioritization and alignment of all assigned projects, and flawless execution in full quality and per agreed timelines. Lead project risk management, change management, and supporting communications as required.

  5. Help identify, resolve/mitigate or appropriately escalate any issues or delays in assigned projects, and ensures all targets are met on time and in full.

  6. Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement.

  7. Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS as it relates to Technology Transfer and Commercialization processes.

  8. Champion operational excellence and continual improvement focus in creating efficient, reliable, user-centric and ultimately successful processes for topic development and deployment/implementation across the network.

  9. In collaboration with the chapter/topic owner, monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures.

  10. Identify industry best practices, champion knowledge sharing and coordinate implementation into QMS as required.

Education Minimum Requirement:

• Degree in Life Sciences, Engineering or related relevant discipline.

Required Experience and Skills**:

• Minimum of 6 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site/GMP environment in site/global quality, operational excellence and/or project management roles.

• Demonstrated senior-level expertise and leadership in quality & compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into executable processes and documentations.

• Broad Knowledge of regulatory requirements for technology transfer, validation and commercialization processes of drugs, devices, biologics, including quality risk management

• Advanced facilitation and project management skills, with strong verbal and written communication skills.

• Expert knowledge of operational excellence principles and methodology (e.g., MPS, Six Sigma).

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.

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

• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.

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

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.

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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.

Other Locations: NA-US-NJ-Whitehouse Station West

Title: Senior Specialist, Global QMS, Chapter 5-Technology Transfer and Commercialization

Primary Location: NA-US-PA-West Point

Requisition ID: QUA007222