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Director, Quality Analytics Data Systems - Laboratory Inform

at Merck in Dover, Delaware, United States

Job Description

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Quality Analytics Data Systems Director that can help drive our Strategic Operating Priorities.

+ Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

+ Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

+ Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

+ Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

+ Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

The Quality Analytics Data Systems Director, reports to the Executive Director of Vaccines Quality Analytics and is responsible for the site-level administration of the Global Laboratory Information Management System (GLIMS) and other automation/analytical tools, including management of master data and validated workbooks, to support analytical testing. The Director is responsible for developing and executing compliant, optimized, and standardized support systems, including incident resolution/first line technical support and proactive system changes, that are responsive to the needs of sites and aligned with global GLIMS administrative processes.

The Director will encourage a lean six sigma mindset across the team, refining processes and metrics for the intake, prioritization, and execution of incoming GLIMS and automation tool change requests to ensure timely testing and release of in-line products and on-time readiness for new product testing. The Director will ensure organizational robustness through enhanced staff training, appropriate redundancy in critical skill sets, and development and enforcement of standardized approaches for management of site GLIMS/analytical tools.

Key Responsibilities

+ Manage geographically diverse team ensuring Proper resource allocation considering capacity and capability | Staff is trained and qualified for required duties | Staff have performance reviews and development plans | Develop and implement an organizational robustness plan

+ Provide strategic and tactical direction/leadership for management of site-level changes to multiple GLIMS systems (release, stability, inventory/standards & reagents modules, and legacy systems), optimizing processes for efficiency and right-first-time execution while ensuring compliance

+ Maintain validated workbooks, other lab automation tools (such as business tools in MS Access, Power BI, and emerging data analytics tools) to support testing laboratories and Quality Analytics Team

+ Establish standardized lean processes for administration of site GLIMS changes with standard target and reporting metrics to eliminate/prevent change backlog at sites.Align level of change management with complexity of associated change

+ Engage with laboratory, IPT, and function leaders to understand needs and embed business-driven priorities into work prioritization to protect compliant supply, including support for Digital laboratory transformation | Across-site standardization initiatives | Data queries and report enhancements to facilitate data reporting needs across the business, such as investigations and critical reagent management

Education

+ Bachelor’s degree in Computer Science, Engineering, Biology, Chemistry, or other related discipline

Required

+ Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

+ Minimum of 10 years of pharmaceutical industry or laboratory automation experience

+ Familiarity with GLIMS systems, including LabWare v8

+ Driving efficiency through Lean Six Sigma and/or development and installation of standard practices and metrics

+ Implementation within change control systems

+ Strong people manager

+ Principled verbal and written communications

Preferred

+ Leading cross-functional and/or geographically diverse teams

+ Managing high volume/high priority workload or other demonstrated experience requiring timely prioritization decisions

+ Prior Administrator roles for GMP system or significant automation system experience

+ Passion for continuous improvement

+ Quality Control Testing or Analytical Development Laboratory

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.

Residents of Colorado

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Job Posting: JC213929787

Posted On: May 19, 2022

Updated On: Jun 03, 2022