Thermo Fisher Scientific, Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 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 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 support.
The Sr. Mgr, IT QA & Compliance is responsible for ensuring system compliance with applicable regulations throughout the software life cycle of development, implementation and maintenance of automated systems that support cGxP processes including Quality oversight and alignment with the IT Corporate Quality Management System. The role is accountable for partnering with IT teams and Quality to ensure the establishment of adequate validation, qualification of infrastructure and defensible data integrity.
- Supports all aspects of Computer System Validation and global IT activities for the systems that support cGxP processes.
- Partner with IT and Business teams in the development, implementation, project management, release, periodic review and maintenance of new and/or updated IT systems.
- Create and Revise existing Risk Management tools as part of a compliant Computer System and Automated Validation approach.
- Support the department’s vision, propose plan(s) and manage project deliverables to prepare the organization to support the growing Computer System Validation needs of the business, including enhancement and optimization of Computer System Validation program.
- Establish effective communication and collaborative relationships with Division business units, global sites and key stakeholders.
- Provide subject matter expertise during regulatory and customer inspections of business sites.
- Participate in the establishment of QA and Validation strategies, needs/requirements and associated plans of existing and new computer systems.
- Maintain current knowledge of industry standards and regulatory requirements.
- 10+ years’ experience in a cGxP-regulated environment, with exhibited knowledge and proficiency of system validation and quality activities.
- 5+ years experience in a management or supervisory position, with direct experience overseeing Validation / Quality Assurance activities.
- Demonstrated leadership, technical, communication, people/relationship management, problem solving, risk management, and project management skills.
- Organizational and management skills to handle multiple global functional groups, with ability to effectively delegate work within a matrix environment.
- Demonstrated ability to organize and enhance the maturity level of the IT and IT / QA functions through strategic plans and mentoring of IT and QA staff.
- Ability to speak, present data and defend approaches in front of an audience and/or inspectors.
- Experience in participating in regulatory inspections, presenting/defending divisional functions in audits or regulatory inspections.
- Ability to comprehend technical information related to computer system development, IT infrastructure, life cycle maintenance, computer validation and regulatory requirements.
- Working understanding and familiarity with FDA, European and Asia Pacific regulatory requirements, industry standards, guidelines and recommendations for computer systems.
- Robust problem-solving skills and attention to detail.
- Multi-cultural exposure and understanding; global thinker.
- Superior leadership skills including experience managing within a matrix environment.
- Ability to collaborate at all levels across the organization.
- Degree in computer systems, science or engineering. Advanced Degree is desirable.
- Detailed knowledge of Computer System Validation, IT Quality Assurance, Software Development Life Cycle requirements and Regulatory Affairs compliance.
- Experience participating in global IT Quality and Computer System Validation initiatives.
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