Sr. Manager Clinical Quality

Job Description

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.

We are the makers of possible. BD is one of the largest global medical technology companies in the world, advancing the world of health™ through innovative solutions.

Demonstrated leadership capabilities with a track record of driving team success and achieving organizational goals. Exceptional aptitude for mentoring, navigating uncertainty, and managing multiple concurrent program objectives. Strong communication across diverse audiences, with a commitment to continuous learning and process improvement. The ideal candidate maintains exceptional attention to detail, thrives in team-oriented environments, and builds strong relationships with internal and external stakeholders.

• Provide direct line management and performance oversight for the Clinical Quality team, including resource planning and project timeline adherence.
• Support and empower the team to apply regulatory standards, industry guidelines, and internal processes across all phases of clinical study conduct.
• Collaborate with study teams to proactively influence clinical operations and ensure compliance; remediate non‑compliance and restore alignment with regulatory expectations.
• Maintain oversight of Corrective and Preventive Action (CAPA) processes and audit responses related to clinical research.
• Oversee the Clinical Quality Management System and drive training/compliance initiatives.
• Establish mechanisms for sharing best practices and lessons learned across the organization.
• Identify and elevate significant compliance risks to Medical Affairs leadership, ensuring timely resolution through remediation strategies.
• Manage performance development for direct reports, including feedback, formal reviews, and succession planning.
• Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff.
• Review and approve team‑related expenses in 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).

BD prioritizes on‑site collaboration to foster creativity and effective problem‑solving. Most roles require a minimum of 4 days of in‑office presence per week, with flexible arrangements for remote or field‑based positions as indicated.

Employment is contingent upon the Company’s receipt of sufficient proof of full COVID‑19 vaccination. Testing may be available or required in some locations. BD considers requests for accommodations pursuant to applicable law.

We are committed to a culture where you can learn, grow, and thrive. Your authentic self is valued and your contributions shape the future of health.

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.