Director, Operational Excellence
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.
Position Overview – Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
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 Director, Operational Excellence, will assume this role for the Global QMS organization. In this capacity, this Director will play a decisive role in managing day-to-day operations and governance in the Global QMS organization. This encompasses management and oversight of the priority projects portfolio, as well as leadership of assigned strategic projects and operational excellence/continuous improvement activities.
Primary Activities: Primary activities include, but are not limited to:
- Maintain full oversight over Global QMS operational activities and related governance, and implement robust processes for regular routine status reporting to Global Head QMS, QMS LT, and other governance bodies as applicable.
- Through collaboration with all QMS Chapter Owners, support the management of a proactive, user-centric and risk-based Quality Management System which ensures that gaps and new requirements are identified and adequately translated into Quality Manuals and global process requirements and are covered by the Quality Plan (continuous improvement).
- Lead cross-functional/strategic project activities within QMS and ensure proper project management, prioritization, and flawless execution in full quality and per agreed timelines.
- Help identify, resolve/mitigate or appropriately escalate any issues or delays and ensure all targets are met on time and in full.
- Take ownership for all metrics and reports issued by QMS (e.g., QMS Health Metrics, new QMS implementation metrics, etc.), and ensure flawless data quality, timely availability, and appropriate follow-up.
- Consult with the Global Head QMS 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.
- Oversee and manage the QMS budget and all contracted 3rd party/consultant/contractor activities, ensuring adherence to quality output, budget and timelines.
- Devise communication strategy for QMS, and ensure timely, transparent and effective communication between QMS and its various stakeholders regarding QMS redesign/transition progress, specific activities or projects, quality plan deliverables progress, or other topics as required.
- Act as the secretary to the QMS Leadership Team; manage leadership team meeting/tier agenda, actions tracking and implementation follow-up.
- Identify industry best practices, champion knowledge sharing and coordinate implementation into QMS.
Education Minimum Requirement:
- Degree in Life Sciences, Engineering or related relevant discipline.
Required Experience and Skills:
- Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably with track record in the area of project management, quality and compliance.Proven track record to successfully manage cross-functional and interdisciplinary teams and large projects.
- Excellent leadership, interpersonal, communication, negotiation and problem solving skills.
- Sound understanding of regulated activities, health authority expectations, and GxP.
- Excellent organizational awareness including significant experience working cross-functionally and in global, cross-cultural teams.
- Relevant experience and track record in MPS/LEAN/Six-Sigma methodologies
- 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 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.
- Capable of working and communicating effectively with all levels of the organization globally.
- Proven ability to effectively initiate and drive change across network
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 email@example.com.
Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Other Locations: Durham-RTP, NC, US; Whitehouse Station West, NJ, US; West Point, PA, US; Rahway, NJ, US; Wilson, NC, US; Elkton, VA, US
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: No
Company Trade Name: Merck