Sr. Director, Quality & Regulatory Compliance, Quality Audit

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 forthe BD strategy surrounding Quality Audits; defining and understanding emerging trends and challenges and the organization’s 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, Chemistry, Biology or equivalent discipline, advanced degree is preferred
• One of the following certifications or equivalent is required; Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence or Exemplar Global ISO 13485 Lead Auditor Certification or Equivalent
• Minimum 20 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company
• Experience with warning letters and other regulatory actions preferred
• Minimum of 5+ years’ experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceutical
• Minimum 15 years of experience in a management position or leadership experience
• Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design)
• Extensive knowledge of medical device regulations, industry or international standards and ability to interpret and apply including FDA QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards
• Advanced knowledge of other international medical device regulations preferred (e.g., China, Saudi, Korea, etc.)
• Comprehensive understanding of auditing principles and ability to perform as a lead auditor
• Strong interpersonal and team dynamic skills in working with organizations to address issues and execute plans, with the ability to lead and influence without direct authority
• Strong analytical skills, mental toughness, and follow through to detect compliance trends and issues as they emerge and to progress solutions in a timely effective manner
• Strong negotiation and facilitation skills
• "Out of box" strategic thinker with strong leadership ability
• Demonstrated ability to effectively collaborate and partner with all levels of management while maintainingan appropriate assertive style is critical

?

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Required Skills

Optional Skills

.