Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
The Vice President, Quality & Regulatory Compliance (VP Q&RC) reports to the EVP & Chief Quality Officer (CQO). The VP Q&RC will be responsible for leading the development and implementation of Quality and Regulatory Compliance plans and objectives across BDX. The initial goals for the role are to develop a best-in-class Compliance organization within BD, elevating the work of the team beyond post market Quality to pro-active Regulatory Compliance across all Regions and Businesses for BD. Functioning to lead a Central Team of subject matter experts, as well as a Global Network of professionals in all regions, the VP Q&RC assures compliance of BD Business, Regions and distribution centers with respect to applicable laws, regulations and standards that govern the design, manufacture, control, distribution and sale of medical products. The VP Q&RC is accountable for evaluating and reporting BD’s Quality compliance risk profile and driving processes to improve this profile across BDX. The VP, QR&C directly manages a core team of subject matter experts in compliance along with the Corporate Quality Audit team. The VP Q&RC also works cross-functionally with teams in Regulatory Affairs, Legal, Medical Affairs, R&D as well as across all Business segments. The primary objectives of this role include:
Assess the current status of the BDX Quality and Regulatory Compliance network and further develop and implement the compliance vision with plans consistent with the overall BD 2025 vision and Global Quality harmonization goals and objectives. Working closely with the CQO, represent Quality and Regulatory Compliance assessment and work plans at the Quality Review Committee of BD Board of Directors. Inspire, motivate and communicate vision for Quality and Regulatory Compliance to leaders across the organization (e.g., Business Unit Presidents, Business Unit Leaders of Operations, as well as regions and functions) and build consensus toward the adoption of and commitment to new harmonized standards. Ensure that key direct and indirect personnel are identified/selected and in place and a system to measure performance/competence is well communicated and in line with expectations. Leadership development; build competency and bench-strength in the Compliance organization
The VP will work within a global environment and will need to have a strong technical foundation and aptitude coupled with the ability to be a “collaborative facilitator” and leader championing the overall mission of BD Quality. He/she must establish and operate processes to ensure an ongoing and self-sustaining improvement in overall compliance both for the short and long term.
The VP needs to be able to operate within a complex matrix and aligned with BD’s Values and Strong Teams Operating Model to efficiently and effectively deliver the goals of the function.
He/she will provide strategic worldwide guidance necessary to gain and maintain global quality compliance standards of excellence for BD Regions for all new and marketed products and will collaborate with the other key functions to determine and promulgate the BD “line to take” with respect to new and emerging Compliance trends and regulations.
Primary Duties (essential functions) Include:
- Ensure quality and regulatory compliance standards are pro-actively identified and translated into effective and streamlined company-wide processes.
- Implement policies related to quality for the organization while assessing appropriate levels of risk associated with specific policy requirements.
- Identify and address gaps related to all relevant aspects of product quality and regulatory compliance (e.g., quality systems, training, registrations, …).
- Assure by process the absence of significant compliance issues and regulatory compliance actions by global governmental agencies.
- Proactively identify and alert organization to present or future compliance issues in a timely manner to avoid potential adverse effects on company image/reputation and/or the business.
- Assure appropriate support to FDA, Competent Authorities and Notified Body inspections.
- Operate an independent Audit Function which can enhance the visibility of BDXs current compliance landscape and ensures transparency to Executive Leadership – pro-actively ensure adequate preparedness for agency and regulatory inspections.
- Think “Out of the Box” to optimize BDX Quality goals and business value and plans and direct resources and activities of Compliance.
- Direct the preparation of the department budgets and maintain operating costs within constraints of those budgets.
- Build strong relationships with internal and external leaders across the regional organizations (e.g., Business Unit Presidents, Business Unit Leaders of Operations and R&D) related to quality and compliance plan issues.
- Inspire, motivate and communicate vision to associates, peers, Business Unit and regional leadership and build alignment toward adoption of and commitment to appropriate standards for Compliance.
- Serve as an active member of the Quality leadership team, providing advice and expertise on issues related to quality.
- Participate in industry trade groups and provide the BD point of view to actively influence the development of industry positions that may impact the regulatory compliance environment.
- Make contacts as needed to develop continual input concerning pertinent scientific, legislative and compliance activities affecting the industry.
- Retain and manage the development of personnel to support the ongoing and progressive business needs, including identifying and developing successors for critical positions.
EXPERIENCE & EDUCATION
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
- Minimum of 15 years of experience in quality management with at least 5-7 years of senior quality and regulatory compliance management experience in an FDA/Competent Authority regulated environment.
- Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP, GLP, GCP. Strong preference for FDA Class II and Class III medical device experience.
- Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post market, and regulatory.
- Demonstrated expertise in working with Regulatory Agencies to address issues.
- Initiative in innovative approaches to quality and compliance in a fast paced changing business environment.
- Excellent written and oral communication and organizational, project management skills.
- Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
- "Out of box" strategic thinker with strong leadership ability.
- As a change agent, motivated to improve organizations and not be satisfied with status quo.
- Strong intellectual curiosity and pursuit of knowledge. Cultivates new ideas. Comfortable with ambiguity and uncertainty.
- Leading Courageously Takes personal ownership on important issues in order to do what is right and achieve organizational success and supports others who do so. Challenges decisions where appropriate.
- Influences Others Presents a compelling case for ideas and initiatives via an appropriately chosen strategy to gain stakeholder commitment.
- Using Insightful Judgment Identifies and analyzes information to make decisions and solve problems.
- Building Relationships and Promoting Collaboration Develops and maintains constructive, open, and honest relationships with others; facilitates the effective interaction and contribution of others to achieve goals.
- Inspiring Trust Gains others’ confidence and trust through principled leadership and sound business ethics.
- Focus on Customers Works closely with customers to analyze and understand their needs and requirements.
- Execution and Driving for Results Plans and executes work processes while demonstrating a strong sense of urgency and commitment to achieving goals.
- Developing People and Talent Focuses efforts on identifying, evaluating, and developing talent, taking steps to ensure needed talent bench strength in the organization.
- Displays Global Perspective Establishes and promotes effective quality and regulatory processes across multiple countries and/or regions and coordinates appropriately with the broader global business.
- Strategic Thinking Driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; a change agent.
- Prudent Risk-taking Inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
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.
Primary Work LocationUSA NJ - Franklin Lakes
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
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To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
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