BD · 1 month ago
Sr. Manager Clinical Quality
United States
Full-time
Remote
Senior Level
7+ years expBD is one of the largest global medical technology companies in the world, committed to advancing health. The Sr. Manager, Clinical Quality will lead a team ensuring regulatory compliance and data integrity across clinical research activities while driving continuous improvement of clinical quality processes throughout the study lifecycle.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
Bachelor's degree
7 years of experience in a quality role within clinical trials (e.g., clinical quality, clinical compliance, or clinical auditing)
Preferred
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)
Benefits
Compensation and benefits programs
Competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
Medical Device Network
2026-01-17
2026-01-16
Med-Tech Insights
2026-01-16
Company data provided by crunchbase