Job Title: IT Compliance and Computer Systems Validation Director
Location: Basingstoke, UK
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
The Director, IT Compliance and Computer Systems Validation (IT-CSV) has primary accountability for the development and continuous improvement of Thermo Fisher’s Quality System to ensure that the required procedures, policies, and processes meet the company’s global business compliance needs. These needs include regulatory compliance, effective quality management, and computer systems validation. The successful candidate: Director, IT-Computer Systems Validation must be results-driven and team-oriented with an enthusiastic attitude, strong leadership, broad perspective, deep expertise in quality systems and regulatory guidance, excellent interpersonal skills, and the ability to influence outcomes in a changing regulatory environment.
The Director, IT-CSV maximizes the effectiveness of the function through direct management of IT Compliance and Validation resources, and through effective collaboration and influence with company leadership, functional area leaders, and key subject matter experts throughout the organization. The candidate must be deeply knowledgeable in cGMP (current Good Manufacturing Practice) as it pertains to medical devices, drugs, and biologics. The candidate must have extensive experience in computer systems validation, and bring a practical risk-based approach to the work.
- Lead the enterprise-wide harmonization, implementation and continuous improvement of Thermo Fisher’s quality systems policies, procedures and practices that pertain to IT compliance and computer systems validation
- Provide oversight, guidance, and specified validation deliverables (e.g. Validation Plans, Validation Summaries, Supplier Quality Audits) to IT project teams that are developing, implementing, and/or supporting validated systems, or qualified infrastructure (inclusive of cloud-computing environments)
- Oversees IT quality and compliance management to ensure internal standards and procedures for computer system validation remain effective at delivering compliant IT solutions
- Lead Thermo Fisher’s IT-CSV function with direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the contribution of the function
- Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on compliance/computer systems validation-related objectives, plans, and priorities
- Integrate computer systems validation activities/deliverables into the IT Project Management Framework
- Develop and manage training programs to assure GxP compliance and advance a quality culture within IT
- Provide expert advice to leadership and functional area managers on quality related issues, including those with company-wide or external impact
- Collaborate with functional areas to establish and update metrics that are reported to leadership to highlight risks and key opportunities for continuous quality improvement
- Provide IT compliance input to manufacturing, quality control, and product development processes to maintain compliance with the relevant quality regulations and international standards
- Provide IT computer systems validation input and resources to author, review and finalize quality-related documentation
- Lead Quality System Management Review meetings with leadership
- Ensure that budgets, schedules, and department performance requirements are met
- Provides regulatory and software quality knowledge and expertise to support high quality application development and deployment while embracing a risk-based approach
- Provide leadership and direction to ensure documentation and testing practices meet applicable regulatory requirements, company policies and quality standards, using sound computer system validation and QA testing practices
- Provides oversight and approvals of risk assessments related to IT systems and platforms
- Works with project managers to establish work scheduling plans in support of project schedules. Provides resource estimates for QA and validation efforts related to project and budgetary planning. Manages resource allocation to approved projects and ensure project timelines are met.
- Monitors new and emerging regulatory requirements and good practice guidance for GxP computerized system, IT controls and compliance
- Keeps abreast of the evolving regulatory policy and industry best practices related Quality systems.
- Other duties as assigned
Qualifications & Experience Required:
- Bachelor degree in Computer Science, or engineering or related field
- Extensive experience in a QA and/or IT Computer Systems Validation leadership role with direct management responsibility for personnel and responsibility for a broad spectrum of IT compliance and computer systems validation elements
- Demonstrated expertise in computer systems validation and experienced in the application of industry best practices
- Highly knowledgeable in regulatory compliance (GxP, 21CFR Part 11, EU Annex 11 etc.)
- Expertise in conducting risk assessments and highly knowledgeable in current industry good practice for risk assessment methodologies and tools, e.g., GAMP-5, NIST, ICH
- Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause
- Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections
- Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
- Detail-oriented with strong organizational skills and high quality standards
- Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents
- Good interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
- Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example with a collaborative style
- Ability to integrate and apply feedback