The Director, Computer System Validation is responsible for the overall ownership, building and maintenance of the Compliance program for Celesticas 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.
This is a Remote position so the successful candidate can be based either in the UK, Ireland, Germany, Austria, Spain or Romania.
Performs tasks such as, but not limited to, the following:
Owns and manages the CSV and compliance program for Celesticas HT market segment
Develop and manage a high performance team of computer system validation analysts.
Management and accountability of Site Validation activities
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 a compliance & 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
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
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: around 25%
Typical Experience and Education:
12+ years of computer validation experience in the medical device manufacturing industry or equivalent.
Bachelors degree in sciences, engineering or IT preferred.