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Location: Salt Lake City, UT, United States
Position Type: Fixed-Term
Job Function: Quality
At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
The Project Manager (PM) in Template Control (TC) will work as a member of the TC Projects team and report to the Manager of TC Projects. Template Control is a diverse team comprised of Production, Projects, Operations, and Innovation groups, and is responsible for TC subassembly manufacturing operations, supporting new product development, conducting product performance investigations, and owning improvement project efforts in collaboration with Biochemistry R&D, Molecular Systems, BioMath, Tech Transfer, Quality Assurance, Reagent Manufacturing, and Manufacturing Support teams.
The TC PM is responsible for owning projects as assigned and seeing the effective and efficient execution of projects and project tasks and activities. This role works closely with all other TC groups to implement new products, processes, and initiatives into TC manufacturing systems. Commitment to BioFire Diagnostics’ corporate culture is essential for success as part of the Template Control Projects team.
Essential Job Duties and Responsibilities
1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Manage department projects by originating and maintaining project plans, coordinating and updating timelines, identifying resource constraints and balancing project dependencies, organizing hierarchies of deliverables, delegating responsibilities and tasks, and keeping stakeholders updated on project progress and potential issues.
3. Work with project steering committees to ensure projects maintain alignment with company objectives and project scope, and coordinates closely with colleagues and collaborators to ensure successful execution and closing of projects.
4. Write risk assessments, specifications, validation plans, batch records, protocols, and reports that support the qualification and validation of Template Control processes in collaboration with TC Innovation group and TC leadership.
5. Effectively compile and communicate observations, data, and conclusions with colleagues in collaboration with TC Innovation team.
6. Integrate quality system regulation and regulatory compliance in all projects.
7. Investigate, experiment, and develop new methods and technologies for project advancement.
8. Use professional concepts, best practices, and innovative strategies to accomplish company objectives in solving complex problems creatively, effectively, and efficiently.
Training and Education
• Bachelor’s degree in chemistry, biology, business, or a related field.
• PMP certification preferred; else must be willing to pursue and obtain PMP certification within three years of hire.
• PgMP certification preferred; else must be willing to pursue and obtain PgMP certification within five years of hire.
• Certification in Kaizen, Six Sigma, Lean 6S, or similar preferred.
• Minimum two years of project or program management experience required.
• Graduate degree in business or physical/life science may substitute for a portion of required project management experience.
• Technical writing experience preferred.
• Coding experience in MS VBA or similar a plus.
• Experience in the medical device industry and knowledge of cGMP/cGLP/QSR/ISO a plus.
Knowledge, Skills, and Abilities
• Familiar with variety of concepts, theories, and procedures in project and program management best practices, and agile in the creative application of appropriate and effective tools to accomplish department goals and initiatives
• Demonstrate practiced managerial skills, including computer literacy in database, spreadsheet, project management, and word processing software
• Structure time effectively, maintain exceptional organization, and efficiently balance multiple and complex concurrent projects in alignment with company priorities
• Master validation strategies as they pertain to the medical device manufacturing industry
• Ability to write reports and manufacturing procedures in conjunction with SMEs
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Demonstrate high-level business judgment and clear communication with cross-functional teams and others at all organizational levels
• Exceptional business etiquette, interpersonal skills, emotional intelligence, and aptitude for successful professional relationships.
Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Ability to perceive and distinguish colors.