# Job Description SummaryThe purpose of this role is to provide strategic and tactical direction and oversight to ensure consistent global leadership for Laboratory Controls\.Laboratory controls includes ensuring that laboratories meet regulatory standards and good laboratory practices\. Primary areas of focus include best practices in relation to test method validation, equipment qualification, good documentation practices, strong tracking mechanisms in terms of sample receipt and testing, out of specification investigations, use of standards, proper sampling plans, and overall assurance that product and processes tested conform to appropriate specifications\.The Associate Director, Global Process Owner \- Laboratory Controls leads a collaborative community of SMEs comprised of Segments, Regions and Functions to define, develop, and implement policy, processes and procedures for Laboratory Controls\. The Associate Director, Global Process Owner \- Laboratory Controls monitors internal and external regulatory observations and trends and implements changes across the enterprise\.This position will also participate in other QMS tactical and strategic activities as needed, including Inspire Quality \(global BD quality strategy\)\. The Associate Director, Global Process Owner \- Laboratory Controls will report directly to Senior Director Quality Management, QE & QC, and is an active member of the Central Quality Team\. The position will interface with other functions such as R&D, Sterilization, and Integrated Supply Chain\.# Job DescriptionIn accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this position is responsible for:+ Owns and ensures Laboratory Controls is effectively implemented E2E across BD+ Establishes and manages Collaborative Community for Laboratory Controls\.+ Serves as subject matter authority on Laboratory Controls+ Leads continuous process improvements and partners with SME’s on key initiatives+ Identifies IT solutions necessary to support Laboratory Controls and works with the IT Teams to implement system solutions across BD+ Defines metrics and measures for the Laboratory Controls+ Establishes training requirements and orchestrate training for the Laboratory Controls+ Monitors performance of Laboratory Controls 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 Laboratory Controls+ Works with standards committee to monitor for external regulatory changes\. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate+ Benchmarks trends in the industry, identify best practices and deploy at BD+ Supports regulatory inspections and audits**Supervision and Budgetary Responsibility:**+ Manages project budgets and IT budgets as needed\.+ Leads collaborative community \(cross business/cross functional network of SMEs\) which will support and drive change for Laboratory Controls**Education and Experience:**+ Typically requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline\. Graduate degree preferred\.+ At least 10 years of experience in a pharmaceutical, medical device or other regulated field \(GMP mainly, GLP, GCP\) with specific experience in Laboratory Controls and working in a laboratory setting\.+ Proven ability as a change agent to drive improvements across a large organization\.+ Demonstrated experience establishing global Quality strategy & oversight, QMS etc\., at business/manufacturing site level in a global company\.+ Strong technical writing experience required\.+ Excellent problem solving and analytical skills\.+ Ability to develop creative approaches and solutions necessary to resolve complex problems\.+ Strong communicator capable of interfacing at senior levels\.+ Proven ability to work globally; ability to lead a global team and lead across cultures and regions\.+ Understanding of the application of quality systems to the medical device industry\.+ Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures\.+ 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 compromised solutions\.+ Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs\. Anticipated travel on a global basis to be around 30%\.Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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\.\#LI\-PRO# Primary Work LocationUSA NJ \- Franklin Lakes# Additional LocationsUSA MD \- Sparks \- 7 Loveton Circle# Work ShiftBecton, 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.