Director, Computer System Validation
Remote, United Kingdom | Celestica
Industry:Computer Hardware / Consumer Electronics
IT / Information Technology
Job Description:52 people have viewed this job
When you join Celestica, it’s more than just a job. It’s about being part of a team of talented individuals who are passionate about what they do every day, and contributing to our forward thinking and collaborative solutions for our teams and customers.
The Director, Computer System Validation is responsible for the overall ownership, building and maintenance of the Compliance program for Celestica's Health Tech (HT) market segment. They will provide direct and indirect supervision to a team of CSV Analysts and coordinate the activities accordingly. The incumbent will work with Global Quality, Enterprise Architecture and IT Platform Leads to execute validation, as well as interact regularly with senior management on matters concerning several functional areas, divisions and/or customers. They will maintain positive relationships with internal stakeholders, key customers, FDA, etc., who have a significant impact on the success of the organization.
Performs tasks such as, but not limited to, the following:
- Develop and implement key changes to policies and procedures that drive risk-based critical thinking approaches
- Define validation plans for IT system deployments that adjust the level of validating and testing to be proportional to risk by differentiating “direct” versus “indirect” impacts to safety, quality and data integrity
- Support team development to adopt validation planning concepts such as risk-based critical thinking, tailored validation planning, focus on intended use, informed risk management
- Work with IT development teams to establish qualified SDLC processes with integrated best practices that drive a risk-balanced approach to validation/assurance
- Owns and manages the CSV and compliance program for Celestica's HT market segment
- Develop and manage a high performance team of computer system validation analysts
- Program management of the IT Compliance deployment program including chairing and leading the HT Steering Committee
- Ownership of the relationship with key HT IT suppliers/partners
- Partner with Global Quality to ensure requirements are met for Good Manufactured Product according to FDA 21CFR Part 11/820, ISO13485 and other applicable regulations
- Acts as a change agent to educate and embed HT Validation in all support functions and teams
- Work with Enterprise Architecture and IT Platform leads to execute validation and change control processes impacting HT products
- Partner with the Director of HT Quality to develop and implement strategies for continuous improvement in IT Compliance
- Work with executive management to determine acceptable levels of risk for the organization.
- Create and maintain Celestica HT Validation policies, procedures, and controls
- Evaluate general and specific training needs; deliver training to support the control environment & associated control framework; communicate governance & compliance objectives, fostering acompliance & risk aware culture
- Accountability and ownership of all HT IT compliance execution activities including schedules, costs/budgets and strategy for validation
- Negotiate with, escalate and drive deployment and adoption of IT Compliance activities, processes and standards at senior levels
- Experience in validation of Computer Systems, investigations, and change control in a medical device manufacturing environment
- Experience applying balanced risk-based approaches to computer systems validation / assurance activities
- Good understanding of GMPs and GAMP standards including validation process
- Knowledge of FDA 21CFR Part 11/820, ISO13485 and other applicable regulations
- Experience at writing/executing validation plans, IQ, OQ and PQ qualification protocols and reports for computer systems
- Relevant experience on Client/Server applications; RDMS Database (SQL Server) applications; SAP system, e-Validator, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems
- Experience in hosting/defending internal or external audits
- Experience rolling out major system/process/policy changes across large global organizations
- Strong relationship management and negotiations skills
- Ability to effectively communicate with Business SMEs, IT team members as well as business users across the globe
- Strong emphasis on customer service and interpersonal skills
- Effective team player and ability to work in a rapidly changing environment
- Proficient personal computer skills including electronic mail, spreadsheets and graphics
- Advanced skills in Excel and Word preferred
- Knowledge of Software Testing Tools is preferred
- Manufacturing Industry experience highly desired
- Excellent analytical, negotiation, problem resolution and presentation skills
- Advanced knowledge of project management
- Advanced knowledge of architecture and solution integration
- Mastery level of knowledge in business partnering and organizational change management
- Mastery in IT Risk Management
- Knowledge of IT Compliance Standards and best practices
- Ability to effectively lead, manage, train and motivate a global group of employees to achieve high performance levels
- Travel requirement: up to 25%
Typical Experience and Education:
- 12+ years of computer validation experience in the medical device manufacturing industry or equivalent.
- Bachelor's degree in sciences, engineering or IT preferred.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.
Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
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