Staff Quality System Specialist I – IT Quality Systems Management - United States
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- As directed by the Sr. Director Quality, the Staff Quality System Specialist I –IT Quality Systems Management is accountable for support of the continued development, improvement and implementation of the IT based Quality Systems.
- This position actively participates in quality guidance and help project & quality network teams for process improvement and continuous improvement activities for IT quality systems.
- Quality & Regulatory functional needs,
- Requirements of emerging and changing regulations,
- Adds value to our partnerships with Operations, and
- Do so within the systems architecture platforms supported by BD
- The System Specialist position will work very closely with the Regulatory and Quality Leadership as well as the Owners of those processes (eg; CAPA, Audit, Medical Device Reporting, etc.) where Systems must be created or enhanced.
- In this position the System Specialist will play a pivotal role in managing the Governance process that maintains the Quality & Regulatory Systems Inventory, System Profiles, Risk Assessment, and Prioritization of new or changing Quality Syst
- Actively support the implementation of a multi-phased Quality & Regulatory Systems improvement effort to further upgrade BD practices in all facets of Quality & Regulatory work systems,
- Manage the design history files for Quality & Regulatory Systems,
- Partner with project teams to develop SDLC documentation to support systems’ implementations,
- Maintain working knowledge of how the Medical Device and Pharmaceutical industries are using the BD supported Application platforms to drive Quality and Regulatory excellence in those operations. Bring those standards /practices into BD in an effective and practical manner.
- Consistent application of Quality system standards to multiple IT Quality system areas
- Develops solutions to routine assigned activities of moderate/high scope & complexity
- Follows applicable Company / Unit procedures and may make updates to IT systems including validation and also for IT systems associated procedures and policies
- Works within and across functions for assigned IT Quality systems
- Working Knowledge of Quality Systems Regulatory requirements, software development lifecycle (SDLC), software validation and application to Company /Unit / site requirements
- Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies
- Subject Matter expert / Super User at Multi Site /plant level for assigned IT quality system (s)
- A minimum of a Bachelor’s Degree. Preferably in engineering (e.g. biomedical, electrical engineering) or computer science
- A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
- Industry Recognized certification in a Quality System Element specialty (e.g ASQ Certified Quality Auditor, Quality Manager) preferred
- The incumbent must be proficient in the System Development Lifecycle (SDLC) and the associated GIT processes use to navigate through the Systems Development Lifecycle for new or changed Quality and Regulatory systems. Knowledge of the Application (ie; SAP and TrackWise) functional capabilities and how to deliver designs that most effectively meet our work process needs is an important skill to possess.
- Practical knowledge of 21 CFR Part 11 and GAMP5. Good documentation practices.
- There is an equally important set of leadership skills needed to perform this role. They include project management, influence management, communication effectiveness, and facilitating conflict resolution.
- Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function.
- Ability to travel 10% of the time both domestically and internationally.
- Consistent application of Quality system standards to assigned Quality system area in medical device or pharmaceutical industry.
- Subject matter expert of Quality Systems Regulatory requirements and application to Company /Unit requirements in regards to SDLC and IT systems validation