Merck Associate Director, Quality Projects Lead in Lansing, Michigan
Our Research & Development's Quality Assurance organization is made up of various teams that provide oversight to ensure subject safety and research integrity throughout the drug development life cycle. Our team helps meet the needs of the business and the expectations of customers and regulators by managing risks that may have a meaningful impact on subject safety or research integrity. We do this by developing and driving risk-based strategies to anticipate risks and provide guidance on managing them.
The mission of the Research & Development's QA organization is to: safeguard the rights and well-being of patients, the welfare of animals, and comply with applicable global regulatory requirements through sound processes and procedures. We provide independent assurance that our company delivers high quality data and clinical supplies.
The Quality Projects Lead will lead our Research and Development divisional QA-driven initiatives that support the Quality Assurance strategic priority of continuous improvement and advancement of the Quality Management System (QMS). The Lead will serve as a QA point-of-contact and IT interface for QA driven initiatives, as well as divisional initiatives that support the QMS infrastructure. Moreover, the lead will be responsible for the project management of technology related projects, as well as, continuous improvement efforts across QA as assigned by leadership.
This individual will be required to work effectively with colleagues across all QA areas to achieve the department’s objectives. The role will communicate information in a clear, concise and timely manner and often will use negotiation, project management, data analytics, and other applicable skills to resolve complex issues. The individual will be able to lead, drive and manage projects that support both the internal projects within Quality Assurance, as well as the collaborative work with our business partners.
Evaluate and evolve quality management system (QMS) infrastructure
Support, advance, and drive updates to our Quality Assurance expanded portfolio of systems in collaboration with QA Subject Matter Experts (SMEs): (Veeva Vault QMS, Veeva Vault QualityDocs, and other systems and additional technology tools)
Collaborate across QA to continuously improve business processes as it relates to the new systems and tools
Support integration of audit resource planning process and tool
Working with QA SMEs, evaluate workflows across to identify opportunities to enhance consistency and a streamlined approach to quality
Collaborate with our Research and Development Labs IT organization on exploration of technologies to solve QA business needs
Lead, understand and participate in the business owner role of System Development Life-Cycle validation activities
Collaborate with the QA Analytics & Insights team as needed on the continued evolution of data analytics and use of metrics
Understand applicable regulations, technology and processes to work effectively with QA functional areas and subject matter experts
Support the development of a Project Management Office (PMO) function within QA
Serve as project lead/project manager for activities, which may include (but are not limited to) the following:
Drive the development and/or improvement of technology solutions related to document, audit and quality issues management
Develop and/or revise standard operating procedures as related to QA systems and supporting practices
Participate in continuous process improvement initiatives as related to QA systems and supporting practices
Analyzing and trending data
Support the development of best practices and resources related to current industry initiatives
Bachelor’s Degree, preferably in a scientific or life sciences discipline.
Experience in implementing and adopting new technology and serving as the business interface with IT
Three or more years of project management related work in a highly matrixed organization
Project Management Professional (PMP) or other project management certifications are a plus
Expertise/experience in aspects of Quality Assurance welcome
Extensive problem solving and critical thinking skills
Excellent communication skills with the ability to tailor messaging to the appropriate audience Ability to identify gaps and recommend improvements to process, driving the associated change
Ability to multi-task across numerous high priority projects in a fast-paced environment
Ability to work independently and with a team
Ability to establish and maintain collaborative partnerships with QA and more broadly to drive consensus
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., Kenilworth, 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Invent. Impact. Inspire.
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Flexible Work Arrangements:
Remote Work, Telecommuting, Work Week
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R115182
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