BD
Director, Quality & Regulatory Compliance, Quality Audit
BD, Franklin Lakes, New Jersey, us, 07417
Job Description SummaryJob DescriptionWe 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.
This position is responsible for the execution of the BD Quality Audit Program in the US & Canada region and others as directed by the WW Sr. Director, Quality Audit & Compliance.
This position is responsible for the implementation, continuous improvement, and management of the BD Corporate Quality Audit Program and for the direct management of auditors who have the overall responsibility for the successful operation of BD quality audits. The incumbent is responsible for providing qualified auditors to conduct quality audits across the organization. Conducts training and coaching of the quality audit team members on the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks.
This position is also responsible for collaborating with regional and business leadership to educate and train the organization, in particular the Quality organization, in the regional Quality Systems Requirements and Regulations. Responsible for supporting and providing insights to the businesses in their inspection readiness activities conducted by Health Authorities in US & Canada region.
Acts as a key contributor in the development of the annual audit strategy. Functions as a subject matter expert for quality and compliance issues in US & Canada region. This position directly and indirectly manages and provides direction to resources assigned to support the regulatory compliance and the audit programs.
Responsibilities:
Manages the Corporate Quality Audit Program including development, scheduling, and implementing plans for management-directed audits
Coordinate and conduct routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, segment, unit, and local procedures and policies
Direct management and oversight of BD quality auditors and audit program managers
Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP)
Develop plans in conjunction with management to address inadequate AAP documentation when required
Maintain the audit system software database to record the status of all audits and associated actions
Provide periodic reports to management based on the audit statuses and defined metrics
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 also be responsible for the assisting in the development of the audit strategy and oversight of the implementation of the department’s projects
This position regularly interfaces with BU and Local leadership teams and compliance personnel to support preparation activities associated with pre-market and post market activities for the assigned Business Units and sites which requires the ability to influence change and gain acceptance/understanding of identified compliance risks and innovative solutions without damaging the relationship and maintaining independence
Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations
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 included certifications or equivalent is required; Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Exemplar Global ISO 13485 Lead Auditor Certification or equivalent
Minimum 15 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 pharmaceuticals
Minimum 10 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
Excellent organizational and project management skills. Ability to effectively manage multiple, complex priorities
"Out of box" strategic thinker with strong leadership ability
Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Ability to participate and provide leadership on teams and maintain positive work environment with those teams
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
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.
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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.
This position is responsible for the execution of the BD Quality Audit Program in the US & Canada region and others as directed by the WW Sr. Director, Quality Audit & Compliance.
This position is responsible for the implementation, continuous improvement, and management of the BD Corporate Quality Audit Program and for the direct management of auditors who have the overall responsibility for the successful operation of BD quality audits. The incumbent is responsible for providing qualified auditors to conduct quality audits across the organization. Conducts training and coaching of the quality audit team members on the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks.
This position is also responsible for collaborating with regional and business leadership to educate and train the organization, in particular the Quality organization, in the regional Quality Systems Requirements and Regulations. Responsible for supporting and providing insights to the businesses in their inspection readiness activities conducted by Health Authorities in US & Canada region.
Acts as a key contributor in the development of the annual audit strategy. Functions as a subject matter expert for quality and compliance issues in US & Canada region. This position directly and indirectly manages and provides direction to resources assigned to support the regulatory compliance and the audit programs.
Responsibilities:
Manages the Corporate Quality Audit Program including development, scheduling, and implementing plans for management-directed audits
Coordinate and conduct routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, segment, unit, and local procedures and policies
Direct management and oversight of BD quality auditors and audit program managers
Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP)
Develop plans in conjunction with management to address inadequate AAP documentation when required
Maintain the audit system software database to record the status of all audits and associated actions
Provide periodic reports to management based on the audit statuses and defined metrics
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 also be responsible for the assisting in the development of the audit strategy and oversight of the implementation of the department’s projects
This position regularly interfaces with BU and Local leadership teams and compliance personnel to support preparation activities associated with pre-market and post market activities for the assigned Business Units and sites which requires the ability to influence change and gain acceptance/understanding of identified compliance risks and innovative solutions without damaging the relationship and maintaining independence
Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations
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 included certifications or equivalent is required; Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Exemplar Global ISO 13485 Lead Auditor Certification or equivalent
Minimum 15 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 pharmaceuticals
Minimum 10 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
Excellent organizational and project management skills. Ability to effectively manage multiple, complex priorities
"Out of box" strategic thinker with strong leadership ability
Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Ability to participate and provide leadership on teams and maintain positive work environment with those teams
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
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.
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