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BD

Sr. Director, Quality & Regulatory Compliance, Quality Audit

BD
Franklin Lakes, United Statesfull_timeVerifiedPosted 8 Nov 2024

About the role

Job Description Summary

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.

As GPO Quality Audit, the Sr. Director is responsible for the BD strategy surrounding Quality Audits; defining and understanding emerging trends and challenges and the organizations readiness to address them.  This position will support the development and improvement of the Internal Quality Audit processes, capabilities and tracking while supporting the continuing improvement of performance, across all Regions. The Sr. Director also provides leadership to the BD Quality Audit Network in support of the BD Quality Audit program and auditor qualification/training.  

Responsibilities:

  • Establishes and maintains WW policies and procedures aimed at harmonizing the BD Quality Audit processes

  • Works across segments and regions on strategies for both improvement and efficiency

  • Liaise with the Quality Leadership of regions and plants to agree on implementation timelines, audit execution and training needs

  • Acts as a Process Owner assisting in the development of the audit strategy and oversight of the implementation of the department’s projects

  • Manages the Corporate Quality Audit Program including development, scheduling, and implementing plans for comprehensive quality system audits taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment. Acts as Audit Program Manager 

  • Direct management and oversight of BD quality audit program and team

  • In collaboration with the Quality Leadership Teams, responsible for the developing the internal quality audit strategy and audit schedule framework ensuring a comprehensive internal quality audit approach is taken and the health of the overall process is monitored

  • Supports development and monitoring of internal audit metrics at corporate, BU and site level. Develop and implement audit reporting metrics to keep management apprised of effectiveness of sites in the resolution of audit compliance issues or commitments

  • Collaborates with IT Teams to implement and maintain technology system solutions for Quality Audits across BD and acts as a business SME. Supports the OneAudit system

  • Provides support to external audit and inspections, as necessary

  • Maintain a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate

  • Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations

  • Manages budgets, schedules and performance standards of quality audit regional teams

  • Work in an office setting and be physically able to travel domestically and internationally (Travel is 30-60%)

Qualifications:

  • B.S. Engineering,

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Company

BD

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