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 SummaryTHIS ROLE CAN BE LOCATED ANYWHERE GLOBALLY
The purpose of this role is to provide strategic and tactical direction and oversight to ensure consistent global leadership for three Quality System Elements; CAPA, Non-Conformance, Root Cause Analysis.
The Global Process Owner leads a collaborative community of SMEs comprised of Segments, Business Units, Regions and Functions to define, develop and implement policy, process and procedure for CAPA, Non-Conformance & Root Cause Analysis. The Global Process Owner monitors internal and external regulatory requirements, observations and trends and implements changes across the enterprise.
This position will also participate in other QMS tactical and strategic activities as needed. The Global Process Owner, CAPA, Non-Conformance & Root Cause Analysis will report directly to VP of Quality Systems and is an active member of the Central Quality Team.
In accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this position is responsible for:
- Owns and ensures CAPA, Non-Conformance & Root Cause Analysis is effectively implemented E2E across BD
- Establish and manage Collaborative Community for CAPA, Non-Conformance & Root Cause Analysis.
- Serve as subject matter authority on CAPA, Non-Conformance & Root Cause Analysis
- Leads continuous process improvements of CAPA, Non-Conformance & Root Cause Analysis and partners with SME’s on key initiatives
- Identifies IT solutions necessary to support CAPA, Non-Conformance & Root Cause Analysis and works with the IT Teams to implement system solutions across BD
- Define metrics and measures for the CAPA, Non-Conformance & Root Cause Analysis
- Build capabilities in Root Cause Analysis across the organization
- Establish training requirements and orchestrate training for CAPA, Non-Conformance & Root Cause Analysis
- Monitors performance of CAPA, Non-Conformance & Root Cause Analysis and reports to senior leadership
- Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements
- Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for CAPA, Non-Conformance & Root Cause Analysis
- Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure, IT solutions and practices based on regulatory changes and implements where appropriate
- Benchmark trends in the industry, identify best practices and deploy at BD
- Supports regulatory inspections and audits
Primary Work LocationUSA NJ - Franklin Lakes
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
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.
Senior Director Quality Management
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.
Manager Medical Laboratory