Job Description SummaryThe Global Process Owner (GPO) Complaint Management & Adverse Events reports to the Vice President, International Quality ("VPIQ"), and is accountable responsible for leading BDX unified BD Global Complaint Management and Adverse Event Reporting process. The job holder defines standards for the operating practices across BDX, leads strategy for the approach to post market compliance through ownership of the process for complaint management and adverse event reporting to government agencies.
The Global Process Owner (GPO) Complaint Management & Adverse Events reports to the Vice President, International Quality ("VPIQ"), and is accountable responsible for leading BDX unified BD Global Complaint Management and Adverse Event Reporting process. The job holder defines standards for the operating practices across BDX, leads strategy for the approach to post market compliance through ownership of the process for complaint management and adverse event reporting to government agencies.
This GPO is the system owner for our global complaint management tools, ensuring effectives software development life cycle management and system compliance. The job holder operates the Global Complaint Network across all Regional and BU SME's to create and maintain world class product complaint & adverse event reporting.
The job holder maintains awareness of Global Regulatory expectations by working with RC and RA leadership and ensures ongoing engagement with the Medical Safety team to refine evaluation guides and reporting expectations in line with trends and signals detected in product data.
He/she will integrate the work within the Regions with BU, Central and Functional Leaders to assure that the organization supports Post Market Quality, and compliance activities and priorities, and current Quality Management strategic goals and objectives to provide effective, efficient quality systems that create customer value addressing elements critical to business success, continuity and competitive advantage. He/she plays a key role in assuring stringent compliance requirements plus is central in identifying product performance issues and drive timely solutions. Active engagement with Competent Authorities is a feature of the role.
The job holder will participate in identifying and leading quality initiatives globally that include any AEG, RCC or Shared Service Centre process improvements plus ensuring BDs tools and processes are "future proofed" to developing regulations and standards.
The job holder needs to be able to operate within a highly 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 guidance necessary to gain and maintain global quality and compliance standards of excellence for complaint management and adverse event reporting for all new and marketed products and will collaborate with the other key functions (RA, Medical, Legal) to determine and promulgate the BD "line to take" with respect to new and emerging trends and regulations within his/her area of responsibility.
Primary Duties (essential functions) Include:
- GPO for Product Complaint Process which includes developing, establishing and maintaining QA programs, policies and processes and Standards around complaint handling and investigations, Medical Device Reporting (MDR), Medical Device Vigilance (MDV) reporting. Operating the Complaint Management Network leader globally across all Regions.
- The job holder ensures compliance with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, FDA 21 CFR 806, ISO 13485, JPAL, CFDA, KFDA etc.)
- The GPO is the Complaint & Adverse Event IT Systems platform Owner, managing SDLC and prioritizing demands and enhancements across all users in the User Base
- Drives development, implementation and management of Global Metrics for Product Complaints and Adverse Event Report. Metrics reported to Regional, Function and BDX leadership.
- Partner with and build strong relationships with leaders across all Segments within BD and their Leaders within the Regions, plus Medical Affairs and RA
- Responsible for promoting and fostering a culture focused on prevention. Responsible for re-
- Actively involved in monitoring significant quality issues and necessary corrective actions in relation to the products manufactured in regional plants or sold in the Regions but manufactured outside of the Regions that may have been discovered during the course of audits, in conjunction with the Vice President International Quality and the BD Segment and BU/platform Quality Manufacturing Directors, as applicable.
- Actively drive key strategic decisions impacting the development of Complaint Management and Adverse Event Reporting Globally.
EXPERIENCE & EDUCATION
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with anadvanced technical degree and MBA preferred.
- Minimum of 15 years of experience in quality management with at least 5-7 years of senior compliance management experience in an FDA/Competent Authority regulated environment including managing of multi-cultural teams executing locally in different countries.
- 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
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.