Director, IT Quality Management Systems
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The Director, IT Quality Management Systems has primary accountability for the development and continuous improvement of Thermo Fisher’s Quality System to ensure that these procedures, policies, processes, and systems meet the needs of the company’s global business. These needs include regulatory compliance, effective quality management, operational scalability, and the flexibility required by a rapidly growing worldwide business.
The Director, IT Quality Management Systems maximizes the effectiveness of the Quality System through direct management of QA resources, tools and through effective collaboration and influence with company leadership, functional area leaders, and key subject matter experts throughout the organization. The candidate should have experience including medical device, in-vitro diagnostics, and clinical laboratory regulations, quality systems, and best practices, extensive management experience, and a successful track record in development and ongoing improvement of Quality Systems in a highly dynamic environment.
- Lead the strategic development, implementation, application, and continuous improvement of Thermo Fisher’s Quality System meeting both operational Maximize equality and regulatory requirements globally.
- Lead Thermo Fisher’s Quality Assurance and Validation function for IT, 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 value of Thermo Fisher’s Quality System.
- Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality-related objectives, plans, and priorities
- Keep abreast of the evolving regulatory policy and industry best practices related Quality systems
- Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for Quality Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
- Provide expert advice to leadership and functional area managers on QA related issues, including those with company-wide or external impact
- Collaborate with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement
- Provide QA input to manufacturing, Quality Control, and product development processes to maintain compliance with the relevant quality regulations and international standards
- Provide QA input and resources to author, review and finalize quality-related documentation.
- Lead Quality System Management Review meetings with leadership
- Identify and suggest functional improvements to the Document Control and Quality Assurance systems.
- Manage and support Quality and validation software (Master Control, Trackwise, and all other related tools/technologies to support company needs in this area).
- Ensure that budgets, schedules, and department performance requirements are met
- Oversees IT Quality and Compliance management to ensure internal standards and procedures for Computer System Validation remain effective at delivering compliant IT solutions.
- Provides guidance to IT department on interpretation and application of procedures applicable to the implementation and operation of IT systems.
- 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
- Other duties as assigned
- Bachelor degree in Computer Science, or engineering or related field.
- Minimum 8 years of experience in a QA leadership and management roles with direct management responsibility for QA personnel and responsibility for a broad spectrum of Quality System elements
- Demonstrated success leading cross-functional development, implementation, application, and maintenance of Quality Systems
- 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, an enthusiastic, optimistic outlook, and a collaborative style
- Ability to integrate and apply feedback in a professional manner
- Is considered an expert in computerized system lifecycle management and has experience in the application of industry best practices
- Well versed with regulatory compliance (GxP, 21CFR Part 11, EU Annex 11 etc.)
- Experience with conducting risk assessment and knowledge of 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
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