BD · 19 hours ago
Senior Clinical Audit Program Manager
Franklin Lakes, NJ
Full-time
Onsite
Senior Level
$163K/yr - $269K/yr
7+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Senior Clinical Audit Program Manager will oversee the Clinical Research Quality Audit program, ensuring compliance with regulations and standards through audits, training, and data analysis.
Medical DeviceHealthcareHealth CareTechnical Support
Responsibilities
As the Sr. Clinical Audit Program Manager for the assigned organization(s), manages the Clinical Research Quality Audit Program including development, scheduling, and implementing plans for comprehensive clinical study and clinical site audits taking into consideration quality metrics, results of previous quality audits and external inspections, industry trends and the external regulatory environment
Coordinate and conduct routine and focused audits of clinical studies, clinical sites, and clinical research processes as assigned to assess compliance with domestic and international regulations and standards, and corporate procedures and policies
Establishes audit teams through the use of qualified BD quality auditors and contracted auditors
Conducts clinical study, clinical site, and process audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures
Follows up with the auditee as required to compile information relating to the audits
Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required
Maintains the audit system software database to record the status of all audits and associated actions
Provides periodic reports to management based on the audit statuses and defined metrics
PowerBI Dashboard & Report Development: Maintain interactive dashboards, develop monthly quality metric PowerPoint slides/scorecards for stakeholders. Identify new visualization tools needed to communicate complex data in an accessible and actionable manner. Support data validation processes of the PowerBI dashboards to ensure data integrity
Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate
This individual will be interacting with individuals at various levels of the organization across multiple sites/BUs and at Corporate during and when following up on audits. This position regularly collaborates with BU and Local leadership teams and compliance personnel to establish and implement schedules for corporate audits and gain acceptance/understanding of identified nonconformances without damaging the relationship with the site
Qualification
Required
Bachelor's Degree required, preferably in the life sciences, advanced degree preferred
Minimum 7 years of experience in clinical research required
Minimum 5 years of experience in a clinical quality, clinical compliance, or clinical auditing role required
Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools
One of the below certifications or equivalent: (Required)
Certified Quality Auditor/ISO Lead Auditor Certified
Certified Quality Engineer
Certified Manager of Quality / Organizational Excellence
Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
Mastery of MedTech 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)
Comprehensive understanding of auditing principles and ability to perform as a lead auditor
Demonstrated proficiency in working collaboratively and partnering with all levels of management while maintaining an appropriate assertive style is critical
Understands team functions, leadership techniques and project management methodologies
Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels within the organization
Strong analytical skills
Effective project management and organizational skills are essential
Ability to effectively manage time and resources
Preferred
Advanced degree, preferably in the life sciences preferred
Prior experience in study management or monitoring in investigational medical device or diagnostic trials preferred
Clinical research certification preferred
Benefits
Annual Bonus 15%
Potential Discretionary LTI Bonus $26,000
Potential reimbursement of phone use
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
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
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-02-09
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