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As the BD Global Services expands its IT and Shared Services capabilities, we need to ensure that our process quality keeps in sync with the expectations of our stockholders, regulators and customers, both internal and external.
As a key member of the Service Control Team within Global Service Management, the Senior IT Validation Analyst is accountable for overseeing quality and validation processes within the Global Services Organization and ensuring alignment with BD Quality Policies. This position is responsible for advising teams, approving records and maintaining SDLC processes to satisfy GxP regulation.
Regulatory Assessment – Works with Project and Compliance teams (FDA/ISO, SOX and GIS/Privacy) to assess the regulatory applicability of IT systems. Facilitates conversations, captures outcomes and publishes meeting minutes. Conducts training sessions and ensures communication of the Regulatory Assessment process.
GxP SME – Works with teams to provide GxP subject matter expertise and validation strategies following SDLC Agile SCRUM and Waterfall methodologies. Collaborates with Corporate Quality as needed to ensure GxP regulatory requirements and company quality policies are met. Approves validation deliverables and deviations. Facilitates CSV and functional risk assessments. Conducts periodic reviews of regulated applications.
Audit/CAPA – Conducts internal reviews against IT processes to identify and remediate audit risks. Supports internal and external audits in conjunction with quality associates and participates in corrective and preventive action efforts.
Process Content Management – Maintains IT process content including SOPs, SWIs, Templates & Forms and training materials and ensures training is being completed. Ensures the latest process information is published for training and use. Conducts periodic reviews to ensure processes are maintained, effectively followed and continually improved.
5-7 years experience in Computer Systems Validation environment with at least 2 years performing in the IT Quality and Compliance as GxP SME reviewer/approver, preferably Pharmaceutical and/or Medical Device industries.
Experienced working with IT Control Methodologies and Processes such as SDLC (Waterfall and Agile SCRUM), Change Management including GAMP5 and ITIL.
Knowledgeable of cGxPs regulations for medical device products, international requirements, and quality system development and management.
Document Management experience using ServiceNow Managed Documents, Solution Manager and/or SAP DMS/ECM a plus.
ASQ Quality/Regulatory and ITIL certification a plus.
Self-motivated and able to work independently with minimal supervision.
Tolerance for working in dynamic project setting with changing priorities, schedules and aggressive project schedules.
Demonstrated leadership and interpersonal skills to set expectations and establish accountability.
Strong written and oral communication.
Ability to work with virtual teams (global environment).
Internal Number: R-312923
About Becton Dickinson
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. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.