BD (Becton, Dickinson and Company) WW Vice President Quality Audit & Risk Management in Franklin Lakes, New Jersey
Job Description Summary
The Vice President Quality Audit & Risk Management oversees audit and risk management activities related to BD’s global Quality Management System.
This position reports to the Chief Quality Officer with a dotted line to the Quality and Regulatory committee of the Board of Directors.
The role has principal charge of providing independent assessment and evaluation of the Company’s system of internal quality controls, assurance of investigations into all known non-compliance and non-conformances and also drives a predictive line of sight by identifying trends and themes. The role is accountable for ensuring the Company’s corporate quality audit and risk management programs provide an accurate ongoing assessment of the Organization’s compliance profile across all its plants and operations including measuring compliance risk and assessing remediation needs and improvement opportunities across the domain. The position is also responsible for partnering with Regulatory Compliance in managing a closed-loop process of reviewing 510(k)’s and technical files.
The incumbent requires significant business auditing experience as well as recent experience working with FDA and other global competent authorities. Demonstrate experience with the US FDA GXP regulations and have a working knowledge on compliance matters involving the design, development, manufacture and distribution of medical devices, combination products, and IVDR and drug products.
As an independent, objective source of assurance and consultation, the Vice President, Quality Audit & Risk Management brings a systematic, disciplined and balanced approach to evaluate and improve the effectiveness of risk management, control and governance processes related to the Quality Management System.
Under the leadership of this role, the Quality Audit organization examines operational and compliance activities, builds an audit program with a risk-based schedule to drive execution of internal quality audits.
The Quality Audit team is responsible for performing unbiased assessments and evaluations of internal controls, risk management, compliance profile assessment and subsequently reports its findings and recommendations to senior management, thereby addressing the strength of internal control systems, enhancing the cost effectiveness and efficiency of operations and maintaining proper accountability for compliance while managing risks appropriately.
The Vice President Quality Audit & Risk Management leads the discussions with senior management, the Quality and Regulatory Committee and external audit bodies regarding audit plans, activities and findings. Provides knowledgeable and objective counsel to executive management and the Quality and Regulatory Committee on critical control, trends and compliance matters. Provides independent opinion on compliance effectiveness and consults on the development of policies and systems.
Through outstanding communication, effective problem solving and active management of ambiguous situations, the role ensures product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of delivering against agreed targets. Through internal and external stakeholder engagement, and organizational design and development, the incumbent produces an effective quality audit process supporting key business drivers.
Primary Responsibilities :
Delivers tangible value to business and functional units through execution of an effective quality audit program and key projects.
Drives the use of the Quality Audit organization as a conduit for top operational talent. Creates an environment where associates are recruited and developed to fill key operational and quality positions throughout the company thereby building organizational capability.
Partners with Business Segments to drive efficient and sustainable solutions to key issues which help achieve strategic goals and increase operational effectiveness and a risk assessed compliance profile. Leverage internal and external subject matter experts to drive issue identification and resolution.
Drives Operational Excellence in audit execution across all Quality audits to ensure effective development, implementation and application of best practice auditing.
Provides expert analysis and counsel on domestic and international compliance matters involving the design, development, manufacture and distribution of medical devices, combination products, IVDR and drugs.
Reports to management on significant issues and trends related to the processes for controlling the activities, including potential improvements to those processes, and agreed management actions through quarterly management review.
Regularly informs the Chief Quality Officer and the Quality and Regulatory Committee on the status and results of the annual risk and audit plan and the effectiveness of the Quality audit program.
Regularly meets with the Quality and Regulatory Committee and provides information which will assist in the proper discharge of the Committee’s responsibilities, including satisfying itself that the Quality Audit function is adequate, effective and efficient.
Establishes a flexible annual audit plan using an appropriate risk-based methodology. Ensures audit findings are appropriately communicated to all stakeholders, including a communication of the significance of the audit findings and any adverse and/or systemic trends.
Reviews and continuously improves the adequacy and application of quality and compliance operating controls.
Coordinates audit efforts with external auditors, and directs the Quality auditing function. Manages activities of the audit team members on implementation of regulatory and Quality system effectiveness audits to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements (i.e. QMS, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.)
Partners with the business segments to ensure external inspection readiness and provides back-room and front-room inspection support as deemed necessary
Sets challenging goals, and serves as a thought leader for organizational capability, continuous improvement, risk management and internal controls.
Position Overview :
Demonstrates a commitment to service, organization values and professionalism through appropriate conduct and demeanor at all times. Adheres to and exhibits BD core values. Operates with the highest levels of ethics and integrity.
Excellent problem solving and analytical skills.
Ability to interface with technical resources and scientifically based teams
Maintains confidentiality and protects sensitive data at all times.
Works collaboratively and supports efforts of team members.
Demonstrates exceptional responsiveness and engagement with key stakeholders, including direct reports, peers, customers, visitors, staff and the broader BDX community.
Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, and combination products partnering with functional stakeholders and experts
Demonstrated ability to employ tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective actions plans
Outstanding operational and people management skills, including: recruiting, retaining and developing talent to execute the responsibilities of the Quality Audit team and to provide a pipeline of talent to the corporation. The incumbent must be capable of building internal and external relationships to develop a best-in-class internal audit function; the ability to build and motivate a high-performance team; ability to assess and develop talent, and provide candid, effective feedback.
Must have a working knowledge of the complexities of a global company and ability to operate within a matrix environment.
The ability to work effectively with other departments and understand the operational and cultural issues relevant to achieve superior operations within their units.
Strategic focus, with ability to identify and prioritize the most critical and impactful issues and opportunities to drive long-term success.
Ability to develop creative approaches and solutions necessary to resolve complex problems.
Manages Directors, Quality Auditors and Quality Specialists who may exercise latitude and independence.
Team of up to 20 associates globally
Education and Experience :
Typically requires a minimum of a BS/MS degree in science, engineering or other relevant discipline with a minimum of 8 years with relevant supervision. Graduate degree preferred.
At least 8 years of experience in a pharmaceutical, medical device or other regulated field (GMP mainly, GLP, GCP) with a minimum of 2 years directly related to the management and administration of quality assurance, quality control, quality systems, regulatory compliance, and/or quality improvement.
Strong technical writing experience required (English).
Strong communicator capable of interfacing at senior levels.
Proven ability to work globally; ability to lead a global team and lead across cultures
Strong understanding of the application of quality systems to the pharmaceutical and/or medical device industry.
Ability to work effectively across diverse areas of BD and manage complex structures
The incumbent must be capable of building internal and external relationships to develop best in class Quality Audit function. Comprehensive knowledge of auditing practices, procedures and principles, sufficient to interpret and analyze complex concepts and apply these in innovative ways.
A recognized expert with a proven track record of 10 or more years managing and delivering best practices in the quality assurance field including Quality Audit services in large, complex , global organizations.
Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromise solutions.
Experience interacting with senior management leadership and Board of Directors regarding internal audit activity, and experience presenting to the Board of Directors.
Ability to travel on a global basis up to 50%.
Primary Work LocationUSA NJ - Franklin Lakes
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