Job Description Summary

Job Description

Be 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 Sr. Director, Quality & Regulatory Compliance, Compliance Program position is responsible for the implementation, continuous improvement and management of the BD Q&RC compliance programs. The incumbent is responsible for establishing strategy and direction for BD compliance programs, for defining and understanding emerging trends and challenges, and the organization’s readiness to address them.

This position is accountable and responsible for ensuring effective implementation of the company’s External Audit management processes in alignment with the overall quality strategy as the global process owner. The incumbent functions as a subject matter expert for quality and compliance issues.

This role provides support to the business units/sites, as well as independent oversight and transparency for compliance remediation activities. Directs and supervises designated leaders who have the overall responsibility for the successful operation of BD compliance recovery programs.

The incumbent requires extensive experience working in or with US FDA, Notified Bodies, and other global regulatory authorities. Demonstrate experience with the US FDA GXP regulations and have a working knowledge on quality matters involving the design, development, manufacture and distribution of medical devices, combination products, IVDR, and drug products.

The Sr. Director will report directly to the VP Quality and Regulatory Compliance and is an active member of the Central Quality & Regulatory Compliance Leadership team.

Responsibilities:

• Supports the development and review of external Health Authority and Notified Body observation responses (appropriate response, investigation, corrective actions, timing, execution), complaints and appeals
• Performs independent review of Health Authority documents linked to compliance programs
• Tracks and monitors Health Authority commitments, additional information (AI) responses and remediation project management. Reports on key quality & regulatory compliance indicators
• Supports driving consistency in field action determinations across BD through active review of field action decisions.  Acts as an independent consultant to BUs regarding field actions
• Monitors and, at times, facilitates Health Authority interactions
• Participates in BD governance forums supporting independent transparency
• Provides leadership and guidance in timely communication/escalation to Executive Leadership of issues associated with external audit findings, regulatory enforcement actions and compliance risk
• Monitors the external Quality and Regulatory environment to share and incorporate lessons learned across industry as well as from health authorities within BD, to help drive continuous process improvement
• Partners with stakeholders to develop strategies and tools to ensure effective inspection readiness and management across the organization and provides strategic support to the businesses and regions where needed
• Identifies needs and supports enhancing regulatory compliance capabilities through delivery of targeted training
• Provides support to external audit and inspections, as necessary
• Maintain a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate
• Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations
• Manages budgets, schedules and performance standards of regulatory compliance recovery team

Qualifications:

• B.S. a Life Science, Engineering, Physical Science or equivalent discipline, an advanced degree or MBA is preferred.
• Minimum 15 years of experience in a management position or leadership experience with at least 10 years of experience in quality, compliance, or regulatory in the MedTech, IVD, or pharmaceutical industry
• Recent experience in working in or 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 dev