Sr. Manager Clinical Quality

Job Description

Summary:

The Sr. Manager, Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team dedicated to ensuring regulatory compliance, Good Clinical Practice (GCP), subject safety, and data integrity across clinical research activities. Reporting to the Sr. Director, Clinical Affairs, this role encompasses strategic leadership, operational oversight, and continuous improvement of clinical quality processes throughout the study lifecycle.

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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 Med Tech 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.

The Sr. Manager, Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team dedicated to ensuring regulatory compliance, Good Clinical Practice (GCP), subject safety, and data integrity across clinical research activities. Reporting to the Sr. Director, Clinical Affairs, this role encompasses strategic leadership, operational oversight, and continuous improvement of clinical quality processes throughout the study lifecycle.

Will demonstrate proven leadership capabilities with a strong track record of driving team success and achieving organizational goals. It includes mentoring, independent decision-making, managing multiple concurrent programs, continuous learning, clear communication, relationship building, and process improvement.

• Provide direct line management and performance oversight for the Clinical Quality team.
• Support and empower the Clinical Quality team in driving the strategic application of regulatory standards.
• Collaborate with study teams to proactively influence clinical operations and ensure compliance.
• Maintain oversight of CAPA processes and audit responses related to clinical research.
• Oversee Clinical Quality Management System and drive training/compliance.
• Establish and promote mechanisms for sharing best practices and lessons learned across the organization.
• Identify and escalate significant compliance risks to Medical Affairs leadership.
• Manage performance development for direct reports.
• Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff.
• Review and approve team-related expenses, ensuring compliance with corporate travel and expense policies.

• Bachelor’s degree.
• 7 years of experience in a quality role within clinical trials (e.g., clinical quality, clinical compliance, or clinical auditing).

• 7 years of experience in a quality role within diagnostic clinical trials.
• 2 years of experience as a direct people leader.
• 2 years of experience in clinical monitoring or study management.
• Mastery of Med Tech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ICH E6).

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…