Associate Director Global QMS
MSD Switzerland
APAC-Malaysia
22 hari yang lepas

Description

MSD 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 MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD 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 MSD’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 Associate Director, Quality Management Systems, is responsible for acting as a cross-functional leader to Simplify, Standardize &
  • Sustain our QMS, for now and the future. The Associate Director will ensure cross functional alignment and act as change agent for the QMS topics, including MSD culture and behavior.

    The 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
  • Provide leadership and MPS tools for the development, deployment and maintenance of assigned QMS topics across the eight QMS chapters.
  • Upskill Topic Owners and SME’s MPS skills required for the development, deployment and maintenance of assigned QMS topics across the eight QMS chapters.
  • Ensure QMS processes are effective and efficient, have the correct level of standardization, documentation has the right level of detail to support the compliant, effective, efficient execution of the process, and the impact to the organization and resources is fully understood.
  • Work with topic owners and subject matter experts to assess system performance to drive continuous improvement.
  • 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.
  • Develop and maintain a robust Management System (Governance / Tier Process) that monitors the process and makes problems visible.
  • Lead development and execution of innovation projects driving operational improvements.
  • Drive best practice sharing and continuous improvements across the our Manufacturing Division network.
  • Consult with the Director of QMS Operational Excellence on strategic topics and projects, identify areas of focus, define and plan activities, ensure and follow / manage execution along agreed project timelines and deliverables, monitor progress, and take corrective action where necessary.
  • Qualifications

    Education Minimum Requirement :

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

  • Lean Six Sigma skills (Green Belt level or higher) and MSD Production System (MPS) expertise.
  • 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.

    Preferred Experience and Skills :

  • 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 our Manufacturing Division network.
  • Your role at MSD 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 MSD, we’re inventing for life.

    Search Firm Representatives Please Read Carefully :

    MSD 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 MSD 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 MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

    Visa sponsorship is not available for this position.

    For more information about personal rights under Equal Employment Opportunity, visit :

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