Job Description Summary

This position is responsible for the implementation and oversight of the BD Clinical Research Quality Audit program.

In this role, she/he is responsible for implementing Clinical Research Quality Audits of BD facilities and providing training and guidance for quality auditors. She/he is responsible for planning of required annual audits and other audits as needed. Additionally, she/he is responsible for managing, analyzing, and interpreting data related to internal quality and clinical audits at the global level. The successful candidate will be responsible for ensuring data integrity of the PowerBI dashboards while identifying any new data needs of the central Quality & Regulatory Compliance Audit team.
She/he monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities.

She/he uses training, experience, and the information collected during audits to assist BD facilities with problem solving and continuous improvement projects as assigned. She/he functions as a subject matter expert for quality and compliance issues.

Job 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 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. 

Required Education and Experience:

• 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 Education and Experience:

• 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

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. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

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

.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA CA - Irvine Laguna Canyon, USA IL - Vernon Hills, USA MA - Lexington

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$163,000.00 - $269,100.00 USD Annual