Sr. Manager Clinical Quality

Description

We are the makers of possible

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 MedTech 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.

Job 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.

The ideal candidate will demonstrate proven leadership capabilities with a strong track record of driving team success and achieving organizational goals. They will possess a natural aptitude for mentoring and developing talent, while maintaining independence and effectiveness in navigating uncertainty. This individual will be highly skilled in managing multiple concurrent program objectives and will exhibit a commitment to continuous learning. Clear and effective communication across diverse audiences is essential, as is the ability to build strong relationships and collaborate with internal and external stakeholders. The candidate should maintain exceptional attention to detail and accuracy, thrive in team-oriented environments, and display strong interpersonal skills. Additionally, experience driving process improvements are highly valued.

Responsibilities:

• Provide direct line management and performance oversight for the Clinical Quality team, including resource planning, project timeline adherence, and compliance with applicable regulations and internal procedures.

• Support and empower the Clinical Quality team in driving the strategic application of regulatory standards, industry guidelines, and internal processes across all phases of clinical study conduct (planning, execution, and closeout).

• Collaborate with study teams to proactively influence clinical operations and ensure compliance; provide guidance to remediate non-compliance and restore alignment with regulatory and organizational expectations.

• Maintain oversight of Corrective and Preventive Action (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, ensuring timely and effective resolution through appropriate remediation strategies.

• Manage performance development for direct reports, including ongoing feedback, formal reviews, and succession planning.

• Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff, ensuring alignment with evolving organizational needs.

• Review and approve team-related expenses, ensuring compliance with corporate travel and expense policies.

Minimum Requirements:

• Bachelor’s degree.

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

Preferred Experience:

• 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 MedTech regulations and standards (e.g., (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 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.