Director, GCS Continuous Improvement

Job Description

Position Overview -Basic Functions & Responsibility

The Global Clinical Supply (GCS) organization is within our company's Research Laboratories and is accountable for managing the 'end-to-end' integrated clinical supply chain across our company's portfolio to enable the execution of any clinical trial using our company's asset. GCS supports more than 300 Phase I-IV clinical trials run in-house, 400+ outsourced or run by partners as well as our company's ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, all in accordance with US and WW regulations, company policies and Standard Operating Procedures.

The Director, Continuous Improvement, will lead Continuous Improvement activities across the organization supporting a CI culture. The role will oversee both strategic and tactical improvement initiatives, kaizen workshops, and cultural activities and will support the roll out of significant metrics as key performance indicators (KPIs), contributing to the overall governance of the performance oversight in GCS. The role will ensure the education of the organization in continuous improvement and lean methodology, project management, change management, knowledge management, quality by design, and appropriate risk management in our processes through coaching and mentoring belt candidates and trainees for the community of practice.

The leader will play a key role in talent development within his/her team but also the overall GCS organization.

Primary Activities

The Director, GCS Continuous Improvement, will be accountable for identification, prioritization, and execution of continuous improvement activities in GCS and across our partner organizations, including, but not limited to, process improvement, change management efforts, and After-Action Reviews (AARs).

Additionally, the incumbent will engage a client group within GCS and be responsible for the implementation of continuous improvement culture, tools, and education across the organization. The Head, CI will closely collaborate across GCS, Global Clinical Trial Operations (GCTO), Global development Quality (GDQ), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Data Management, Translational Medicine, and our Research & Development division (including our research and development division's Quality Assurance/QA and IT).

Primary activities include, but are not limited to:

• Actively create a culture in which Continuous Improvement becomes the organizational norm.

• Process design/improvement projects/strategic initiatives across the organization

• Continuously identifies opportunities to improve, simplify, standardize, and optimize processes in collaboration with functional areas.

• Analytics & Metrics - Develops and maintains performance, quality, and compliance related analytics and metrics (reports, dashboards, Key Performance Indicators/KPIs)

• Seeks ways to innovate and/or further automate the use of data and new capabilities.

• Identify, train and coach in lean concepts.

• Continuously evaluate opportunities for creating additional connectivity, and share learnings, between partner organizations

Education & Experience:

• Bachelor's degree or equivalent required. A graduate degree in scientific discipline would be beneficial. A LSS black belt certification or equivalent experience is required. Extensive experience in facilitating kaizen workshops and leading complex projects. Understanding of Clinical supply chain and clinical trials understanding including GCP & GMP.

Skills Include but not limited to:

• A dedication to solving complex and challenging problems with a creative mind and imaginative strategies.

• Strong Influencing and negotiation skills

• Ability to lead, create future state, and deliver results.

• 7-10 years in the implementation of a variety of lean six sigma tools to evaluate and improve business processes with at least 7 years coaching and leading process improvement teams.

• Demonstrated ability to develop strong, trust based, collaborative relationships to drive change and execute on priorities with a diverse group of stakeholders.

• Strategic thinking and independent decision-making abilities

• Demonstrated ability to communicate clearly, effectively and tactfully to interact with different global professional levels and external stakeholders.

• Proven track record of successful deployment of continuous improvement projects, across different modalities and business units

• Must have strong understanding of GMP, GCP, and data integrity expectations from regulatory agencies.

• Excellent written and verbal communication

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R242237