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Thermo Fisher Scientific Sr Manager, IT in Greenville, North Carolina

What Will You Be A Part Of?

The IT Manager - Quality Assurance, Regulatory Affairs and Compliance (QARAC) - Infrastructure is responsible for leading the Thermo Fisher QARAC network infrastructure qualification and related compliance deliverable requirements. In this role the Senior IT Manager will lead a team of resources focused on ensuring the network installations for new 'greenfield' projects as well as mergers and acquisitions meet compliance requirements of Thermo Fisher's IT Quality Management Framework. The Senior IT Manager will identify key IT processes related to infrastructure qualification, operational management and the controls necessary to ensure compliance with all applicable regulatory requirements.

The ideal candidate will have proven background with qualifying network infrastructure in accordance with regulatory requirements and GAMP5 in a regulated (pharmaceutical manufacturing preferred) environment, exhibit strong planning and organizational skills, provide excellent leadership, negotiation and mediation skills, and a demonstrated ability to work with all levels of the organization.

How Will You Make An Impact?

You will contribute as a member of the IT Corporate Solutions and Integrations, Quality Assurance, Regulatory and Compliance (CSI-QARAC) Team enhancing our corporate compliance policies, procedures and programs. You will provide compliance leadership to the members of the CSI-QARAC team, build excellent business partnerships with corporate IT, and be the QARAC point-of-contact with the IT Mergers and Acquisition team planning and execution integration efforts.

What Will You Do?

  • Primary responsibility will be to manage the CSI-QARAC IT Compliance Infrastructure Qualification demands

  • Partner with the IT M&A function to ensure all IT infrastructure align with GAMP5 Qualification, global quality and security requirements

  • Lead the delivery of IT Integration infrastructure compliance project deliverables on time, within budget and in adherence to quality goals

  • Act as the subject matter expert (SME) for CSI-QARAC Network Infrastructure Compliance to establish, maintain and enhance standards in accordance with 21CFR, GAMP5, Annex 11, COBIT 2019®, ISO, and any other related regulatory compliance requirements

  • Deliver and manage infrastructure project related reporting and metrics to stakeholders

  • Work directly with global/group quality and IT partners to drive compliance across the network.

  • Identify and mitigate quality and security risk within corporate IT solutions/processes and be a trusted partner to the Thermo Fisher business groups

  • Collaborate with global/group functional partners and site teams to draft, review, and provide compliance approval for requirement and qualification documents for infrastructure used in GXP environments.

  • Hire, train, setup SMART career development goals and conduct performance reviews as per company policy.

  • Develop and implement team training for corporate IT that meet regulatory requirements for GXP environments at scale

  • Embody Thermo Fisher's 4i values: integrity, innovation, intensity, and involvement

  • Comply with company's Global IT Policies & Procedures

How Will You Get Here?

  • Must have a minimum of 6 years of experience in a leadership role

  • Minimum of 3 years of experience working in network infrastructure qualification in the regulated industry

  • Functional understanding of IT infrastructure including basic networking, server operating systems, and Active Directory group policy objects

  • Must have expertise in enterprise IT systems such as QMS, ERP, CRM, PLM, Supply Chain or eCommerce

  • Must have people management experience with proven track record of managing high performance teams

  • Proven affinity and understanding of quality, regulatory and compliance best practices

  • Proven IT leadership and project management skills

Education:

  • Bachelor or Master's degree in Computer Science, MIS, IT, Business, Accounting or equivalent experience

  • 6+ years of experience managing a team of IT professionals in an FDA regulated (GXP), fast-paced, large company environment

Knowledge, Skills, Abilities

  • Ability to work in a highly matrixed environment, inclusive of conflict resolution

  • Capacity to make decisions or recommendations based on area of assigned responsibility. Uses good judgement in gathering input for decisions

  • Ability to quickly understand and adjust to changing business needs

  • Strong negotiating and influencing skills

  • Strong management skills and understanding of technology lifecycle management

  • Strong written and verbal communication skills

  • Strong customer service/relationship building skills

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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