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,