Program Manager MMS Projects & CAPA

Program Manager MMS Projects & CAPAThis role partners with cross-functional teams across R&D, Quality, Operations, and Regulatory to execute high-impact projects, with a strong emphasis on CAPA (Corrective and Preventive Action) excellence. This Program Manager is responsible for overseeing the BD Quality CAPA portfolio, ensuring issues are effectively investigated, resolved, and prevented from recurring. The role will lead process improvements, drive operational efficiency, and ensure compliance with FDA regulations, ISO standards, and internal quality procedures. The ideal candidate brings strong project management capability, change-management experience, and the ability to navigate ambiguity while achieving timely and measurable results. This position will be located in San Diego at our Medication Management Solutions headquarters, working with cross-functional teams. We are looking for a dynamic Program Manager to drive strategic projects, with CAPA process transformation being one of the major focus areas. Project management expertise will play a key role in helping to achieve timely and successful completion of projects across our entire Quality Management System. The ideal candidate will bring to the table 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. As a Program Manager MMS you will have responsibility for driving the BD Quality CAPA portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don't recur. This position will be responsible for additional Quality Management System project work as needed. Responsibilities may include the following and other duties may be assigned: Lead and drive strategic quality and operational improvement initiatives across the organization, ensuring alignment with business objectives and regulatory requirements. Develop project plans, timelines, and resource allocation strategies to ensure successful delivery of cross-functional programs and initiatives. Facilitate stakeholder engagement and communication across all levels of the organization to drive program success and organizational change. Monitor program progress, identify risks and dependencies, and implement mitigation strategies to keep initiatives on track. Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with BD internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases. Lead the development and implementation of CAPA processes within the R&D department. Ensure compliance with FDA regulations, ISO standards, and other applicable quality standards. Facilitate cross-functional teams to identify root causes of issues and develop effective corrective and preventive actions. Monitor CAPA activities for timely execution and effectiveness of implemented actions. Prepare and present CAPA reports and metrics to senior management. Conduct training sessions for R&D staff on CAPA processes and best practices. Collaborate with Quality Assurance and Regulatory Affairs teams to maintain consistent quality standards. Act as a point of contact for CAPA-related inquiries and provide guidance to team members. Support continuous improvement initiatives by utilizing CAPA insights to enhance product development processes. Devises and implements methods and procedures for inspecting, testing, and evaluating the effectiveness and accuracy of corrective actions ensuring no impact to products, processes or patient safety. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with regulatory requirements. May support CAPA in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. May participate in CAPA review board activity and support audits. Must Have (Minimum Requirements) To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor's degree in Engineering or Science degree with a minimum of 5 years of project management experience within the medical device industry, with expertise in CAPA and Quality Systems preferred Nice to Have (Preferred Qualifications) Experience in medical device, pharmaceutical and/or a comparable regulated environment. Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques. Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques. Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight. Experience working with non-conformances, corrective and preventive actions. Strong analytical, process improvement, critical thinking, and decision-making skills. Ability to educate people in the CAPA program. CAPA documentation systems experience (e.g. Trackwise). Influence management skills: ability to work constructively across all functions of the organization as well as external customers. Project management skills. PMP, lean and six sigma green or black belt. Experience reviewing technical documentation. Strong written and verbal communication skills. Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and other applicable quality standards. Experience with internal and external audits. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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 will be considered pursuant to applicable law. A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information: $124,700.00 - $205,800.00 USD Annual