Sr. Project Manager (CAPA)
BDAbout the role
Job Description Summary
Responsible for managing the execution of programs and/or projects consisting of single or multiple projects and/or programs. May manage project and/or program managers within assigned program and/or project. Works within the constraints of budget, schedule and scope while managing risk and ensuring adherence to established processes and methodologies.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
This position will be located in San Diego at our Medication Management Solutions headquarters, working with cross-functional CAPA action item leader and CAPA owners. We are looking to transform our CAPA process to a best in class system, where project management will play a key role in helping to achieve timely and successful completion of CAPA projects across our entire Quality Management System. The ideal candidate will offer a positive attitude, will be a self-starter that also has change management experience and the drive to achieve quick wins in sometimes ambiguous situations.
Responsibilities:
Candidate must demonstrate strong practical experience in Project Management leadership managing large and complex interrelated programs within the medical device industry.
Demonstrated ability as a Project Management leader experienced with industry standard project management methodology and techniques (PMBOK).
Strong eye for business, strategically aligns program achievements to organizational success.
Strong leadership and management skills, with demonstrated success working within a matrix organization, and strong presentation skills at all levels of the organization.
Experienced Quality Leader with strong problem-solving skills, able to find innovative ways to resolve issues. Trained in Lean Six Sigma, Kaizen, or other problem-solving methodologies.
Knowledgeable on 21CFR 820, ISO 13485, ISO 14971, MDR.
Demonstrated understanding of budgeting and resource allocation.
Accountable to initiate, plan and drive a platform of inter-related programs throughout the program lifecycle.
Accountable to ensure continuity of MMS Quality Program Management methodologies, output of records, reports, metrics and program(s) communications.
Collaborates and supports program initiation.
Accountable to drive programs through planning, execution and close out phases.
Accountable to establish program governance and metrics for success.
Accountable for program communication with teams, peers, and leadership and budget (s).
Manages program(s) risks and issues proactively taking corrective measurements.
Manages program/project interdependencies by balancing resources based on business priorities.
Performs other related duties as assigned by manager.
Must Haves:
Technical or Business Bachelor’s degree required.
Minimum 3 years direct experience managing platforms and or inter-related programs of high complexity.
Class II or Class III Medical device industry experience.
Experience leading projects within quality organizations.
Strong understanding of medical device quality systems, FDA, and ISO standards.
Experience leading virtual teams.
Experienced in problem solving methodologies.
Experience across the entire product lifecycle.
Highly Desirables:
DFSS, Six Sigma, Lean Six Sigma Green Belt Certified.
ASQ Manager of Quality Certified.
Lead Auditor Certified.
PMP Certified.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation
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