Job Description Summary
Reporting to the Associate Director of Corporate Quality, the Staff Quality System Specialist is accountable for developing and executing strategy of validation for quality system software (non-product software). This includes establishing policies, procedures and tools and supporting validation, implementation and change management of key quality IT systems and manufacturing equipment. The Staff Quality System Specialist works on assigned IT quality system projects as the validation and compliance expert to ensure efficient project execution and compliance with BD computer system validation policy and IT System Development Life Cycle (SDLC) procedures. The Staff Quality System Specialist provides guidance to the business owner, process owner, and end-user stakeholders throughout the IT demand portfolio process (Idea to Realization - I2R) and SDLC process. This includes, but not limited to, key quality and regulatory systems such as LIMS, Trackwise, Blue Mountain, Regulatory Information Management (RIM), Product Information Management (PIM). In this role, the Staff Quality System Specialist works with the businesses and project team to create and approve key validation documents such as Regulatory Applicability Assessment, User Requirements Specification, Functional Requirements Specification, Risk Assessment, Validation Plan, Part 11 Assessment, OQ/PQ test scripts, Traceability Matrix and Validation Summary Report. Through outstanding communication; effective problem solving and organizational skills; the Staff Quality System Specialist helps Corporate Quality group in implementing and expanding the usage of key quality IT systems that are compliant with internal BD procedures and relevant global regulations. Success is measured in supporting the project teams and sites to deliver the needed solution and deliverables on the annual basis.
* Update and improve current policy, procedures and templates for computer system validation to improve efficiency and effectiveness using risk-based approach and validation right-sizing.
* Maintain computer system validation toolkit and provide training at the business, site, and functional levels.
* Assume the GxP SME / Quality Representative role on assigned quality or regulatory IT system implementation project to provide validation guidance and oversight to ensure projects are compliant with BD computer system validation policy and IT SDLC procedures.
* Provide training, mentoring and coaching on software validation for PLC-based automated manufacturing equipment (AME) in conjunction with process validation.
* Provide guidance on validation of local business application, database/spreadsheets, and lab equipment at the business unit or site level.
* Ensure project activities and deliverables are executed in accordance with internal BD policies and procedures such as IT SDLC, validation and change management.
* Author or provide quality approval of key validation documentation including, but not limited to, Regulatory Applicability Assessment, User Requirements Specification, Functional Requirement Specification, Risk Assessment, Validation Plan, requirement-based OQ/PQ test cases, Traceability Matrix, Validation Summary Report.
* Provide quality guidance on projects following either water fall or agile SDLC methodologies.
* Work directly with the businesses and plants in defining roadmap/strategy for update and enhancement on key quality IT systems.
* Lead, support, and perform software vendor audits and internal quality audits.
* Perform periodic and/or preventive audits on the key regulated IT systems to make sure validation and change management (including changes at the global and local levels) are adequate to maintain the validated state of these systems.
* Monitor, measure and improve the efficiency and effectiveness of the implementation these key quality IT systems.
* A minimum of a bachelor's degree required in Computer Science, Information Technology, Engineering, or Science discipline.
* A minimum of 5 years or practical experience and proficiency with System Development Life Cycle (SDLC) in a regulated environment (medical device or pharmaceutical) for IT systems supporting quality management system (QMS).
* Practical knowledge of 21 CFR 820, ISO 13485, 21 CFR Part 11, GAMP5, and good documentation practices.
* Practical knowledge with Trackwise, LIMS, SAP, Training system, Blue Mountain, Documentation Management System is a plus.
* 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.
* Excellent analytical, technical, and problem solving skills.
* Ability to influence without authority at different levels of the organization.
* Excellent and experienced meeting and presentation skills.
* Ability to travel up to 10% of the time both domestically and internationally.
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.
Primary Work LocationUSA NJ - Franklin Lakes
About Becton Dickinson
Becton Dickinson is a global medical technology company that develops, manufactures, and sells medical supplies, devices, laboratory equipment, and diagnostic products.