BD (Becton, Dickinson and Company) Senior Manager, Process Manager in San Diego, California
Job Description SummaryIn this newly created position reporting to the Regulatory Operations Systems Director, the Senior Manager of Global Processes will play a lead role in building and refining BD's regulatory information management and document management system processes. The Sr. Manager, RA Processes guides a global/local team of regulatory professionals and other functional team members by overseeing the end to end delivery of dedicated improved process framework.
Regulatory system adoption and usage
Ensuring that the Process and Governance Structure is fit-for-purpose
Defining the Business Cases for the various RA processes
Ownership of processes, implementation and maintenance for Global RA Processes.
Ensuring there is optimal fit between people, process, technology (tool) and steering
Taking a ‘helicopter view’, overseeing and ensuring integration of new processes and linked with technology.
Lead and communicate changes to the Process and Governance structures
Initiate improvements in the process, steering mechanisms, and people.
Review integration issues between the various processes
Provide IT support, business analysis, validation expertise, technical writing, project management learning development and training for document management and regulatory systems.
Plan and manage complex projects and prioritize workload
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with BD and external standards
Maintain appropriate communication within the RA function, QA, R&D, and other functions primarily at the project team level
Assess impact of new technology and processes and provide feedback.
Provide support for all aspects of regulatory submissions including related technology, validation, document management and best business practices, not only for the regulatory arena but for all departments (clinical, quality, nonclinical) that provide documents and data to regulatory submissions.
Set team, group, or service objectives to assure they align with the Regulatory strategy
Provide technical and strategic input for regulatory decisions
May manage budget
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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