Kenilworth, New Jersey

Job Description

The Quality Management Systems (QMS) Associate Director reports to the QMS Director overseeing QMS chapters 6 (manufacturing), 7 (laboratory systems) and 8 (continued product assessment & reporting) within the Quality Compliance Organization as part of our company's Manufacturing & Supply (OMS). 

Critical to the success of this role is, in alignment with the Quality Compliance organization and key stakeholders is to assist with the execution of the strategy for development and deployment of the OMS Quality Management System as our company stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of our company.

This position is key in our company's effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our products, with an objective to enable consistently compliant product quality, continuous improvement and effective life-cycle management.  The position, in alignment with the OMS Quality Compliance team and key stakeholders, will help define the strategy for development and deployment of the OMS Quality Management System as our company stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of our company.

The QMS Associate Director is responsible for the development of processes, procedures and corresponding controlled documentation and systems within topic(s) assigned within the scope of QMS Chapters 6 (Manufacturing), 7 (Laboratory Controls), and 8 (Continued Product Assessment & Reporting). 

The QMS Associate Director 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

Main Activities:

Primary activities include, but are not limited to:

  • Responsible for obtaining input into the design and development as well as implementation of the OMS QMS deployment strategy related to assigned topics within chapters 6, 7, and 8.

  • Lead cross-functional global teams developing content for the chapter, and interface with other chapters/topics, and stakeholders across the network as required.

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

  • Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment.

  • 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.

  • Help identify, resolve/mitigate or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full and to quality.

  • Drive the development, implementation and realization of permanent inspection readiness for assigned topics.

Education:

  • Bachelor's Degree in science, engineering, or related areas of study.

Required Experience and Skills:

  • Minimum of 8 years experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred.

  • Demonstrated 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.

  • Subject matter expertise in regulatory requirements and expectations for manufacturing, laboratory controls or continued product assessment & reporting

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

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

  • Proven ability to lead 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.

  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.

  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.

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

  • Proven ability to effectively initiate and drive change across a diverse and multi-functional organization

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. 

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If you need an accommodation for the application process please email us at staffingaadar@msd.com
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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R85125

Kenilworth, New Jersey

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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