As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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Job Description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters.    

Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. 

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

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.

Required Skills

Optional Skills

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

NA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$143,900.00 - $237,600.00 USD Annual