Associate Director, Quality Systems & Architecture

BD (Becton, Dickinson and Company)•San Diego, CA

47d•Onsite

About The Position

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. Responsibilities: This leader must develop strategic quality programs to oversee and foster the following areas and represent QMS expert-level leadership and guidance for a dedicated team. QMS architecture: QMS certificate change notifications; change in scope of activities performed at sites; and site transfers QMS compliance: front room host for external audits and inspections; QMS expert to prep SMEs for front room; Management Review host; identifying QMS gaps in organizational structure, competency, or technical areas; implementing solutions to close QMS gaps, including but not limited to CAPAs, projects, workshops, and training; authoring CAPA investigations QMS harmonization activities: MMS lead for Inspire Quality program to harmonize processes with Global expectations and between MMS platforms (including Class I/II medical devices and non-medical devices) QMS integration activities: QMS impact assessments for integrating acquisitions, platforms, products, sites, etc.; due diligence activities for potential acquisitions

Requirements

A BS degree in a technical field (Engineering, Science, Math/Stat)
Minimum 10 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.
Minimum 5 years experience directly managing Quality professionals.
Demonstrated expert-level knowledge of QMS.
Ability to travel domestically and internationally, up to 25%
Strong leadership skills with demonstrated ability to deliver excellent results
Strong project management, team skills, and influential management
Experience leading or supporting FDA and/or Notified Body inspections
Excellent communication skills (up, down, and outward)

Nice To Haves

Experience in Regulatory Affairs preferred.
Experience in metrics, data analytics, and/or statistical analysis preferred.
ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.

Responsibilities

QMS architecture: QMS certificate change notifications; change in scope of activities performed at sites; and site transfers
QMS compliance: front room host for external audits and inspections; QMS expert to prep SMEs for front room; Management Review host; identifying QMS gaps in organizational structure, competency, or technical areas; implementing solutions to close QMS gaps, including but not limited to CAPAs, projects, workshops, and training; authoring CAPA investigations
QMS harmonization activities: MMS lead for Inspire Quality program to harmonize processes with Global expectations and between MMS platforms (including Class I/II medical devices and non-medical devices)
QMS integration activities: QMS impact assessments for integrating acquisitions, platforms, products, sites, etc.; due diligence activities for potential acquisitions

Benefits

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.

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