Director, Quality & Regulatory Compliance, Compliance Programs

Job Description SummaryBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.The Director, Quality and Regulatory Compliance, Compliance Programs is responsible for helping to shape, implement and support the maintenance of the BD Q & RC compliance programs. This role contributes to the definition of the strategy and determines the tactics required to execute various elements of the program. Through outstanding communication, effective problem solving and active management of ambiguous situations, the Director, Compliance Programs provides heightened oversight and governance of compliance recovery programs.The Director works directly with business units and sites to drive enhanced quality and regulatory compliance through coordination, tracking and monitoring of health authority responses, commitments and inspection readiness.This role requires demonstrated experience with the US FDA GXP regulations and a working knowledge of quality matters involving the design, development, manufacture and distribution of medical devices, combination products, IVDR, and drug products.The Director will report directly to the VP Quality and Regulatory Compliance and is a member of the Central Quality & Regulatory Compliance Leadership team.Responsibilities : Support the Quality & Regulatory Compliance Leadership Team in designing and implementing compliance programs.Provide tactical oversight and tracking of planning and execution of recovery activities.Act as an independent reviewer / approver on CAPAs and quality plans for assigned compliance recovery programs.Work with business unit / site leadership to ensure adequate and capable associates are allocated to quality and regulatory compliance remediations.Provide guidance to ensure timely execution of activities defined for compliance programs. Ensure compliance program activities align with relevant regulations and BD global processes.Escalate risks to timely and effective completion of compliance programs, including prioritization, resource, capability and documentation concerns.Develop and maintain a set of tools and templates for reporting on status of compliance programs to various levels of management.Be perceived as a thought leader possessing subject matter expert knowledge of global regulations.Demonstrate a commitment to service, organization values and professionalism through appropriate conduct and demeanor always.Operate with the highest levels of ethics and integrity.Exhibit strong problem solving and analytical skills.Maintain confidentiality and always protect sensitive data.Work collaboratively and support efforts of team members.Have a working knowledge of the complexities of a global company and the ability to operate within a highly matrixed environment.Work effectively with other departments and understand the operational and cultural issues relevant to achieve superior results.Maintain a strategic focus, with the ability to identify and prioritize the most critical and impactful issues and opportunities to drive long-term success.Develop creative approaches and solutions necessary to resolve complex problems.Qualifications : Minimum BA / BS degree or equivalent in a Life Science, Engineering, or Physical Science; Advanced technical degree or MBA preferred.Minimum of 10 years of experience, with at least 5 years of management experience in quality, compliance, or regulatory in the MedTech, IVD, or pharmaceutical industry.Recent experience in quality management, compliance or an audit function working with US FDA, Notified Bodies, and other global regulatory authorities.Demonstrated comprehensive expertise in the applied interpretation of the US & worldwide regulatory standards and laws applicable to the medical device industry, e.g., ISO, QSR, GMP, GLP, GCP, MDR, IVDR, MDSAP.Anticipated travel on a global basis to be around 20-40%.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.Why Join Us?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.To learn more about BD visit https : / / bd.com / careersBecton, Dickinson and Company is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.#J-18808-Ljbffr