Job Details

Manager, IT - Infrastructure Qualification - Remote Opportunity

Advertiser
Thermo Fisher Scientific
Location
Boston, Massachusetts, United States
Rate
-
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Your work will have real-world impact, and you'll be supported in achieving your career goals. The IT Manager for Quality Assurance, Regulatory Affairs and Compliance (IT-QARAC) - Infrastructure Qualification will lead the qualification effort for infrastructure component(s) used by computer system validation (CSV), Mergers & Acquisitions (M&A) and site expansion projects in support of new and existing manufacturing and laboratory sites. The ideal candidate will identify key IT processes related to infrastructure qualification based on applicable regulations, industry guidance, company policies and standard operating procedures. How will you make an impact? You will contribute as a member of the IT-QARAC Team by improving the infrastructure qualification policies, procedures, and program. You will provide qualification direction and leadership to the members of the technical and validation teams, build excellent business partnerships within Business Groups and Global IT, and be the workstream lead during IT M&A projects which require infrastructure qualification efforts What will you do? + Primary responsibility will be to lead the CSI-QARAC IT Compliance Infrastructure Qualification demands. + Identify and determine the infrastructure qualification strategy. + Coordinate qualification activities with technical teams and sites. + Independently author qualification documents such as qualification plans, qualification protocols, qualification forms, and summary reports + Independently review and approve architecture diagrams, design specifications, vendor documentation, protocols, and forms with a focus on infrastructure qualification lifecycle requirements. + Partner with the IT M&A function to ensure all IT infrastructure align with GAMP 5 Infrastructure Qualification guidance recommendations. + Collaborate with global/group functional partners and site teams to draft, review, and approve qualification results for infrastructure used in GxP environments. + Work with regional project teams to ensure the Global qualification strategy is understood and followed. + Approve technical change controls to evaluate their impact to the infrastructure qualified state. + Lead the effort to periodically review and update infrastructure qualification related procedures, templates, protocols, work instructions, and forms as needed to improve the qualification program. + Maintain up-to-date knowledge on quality system requirements as they apply to infrastructure in accordance with GxP regulations, GAMP, industry standards, policies, and procedures + Support the IT QA Compliance department during the qualification of IT suppliers. + Work with the Sr. Manager, IT to build funding requests and team strategy to include functional capabilities, tools, applications, staffing, etc. + Hire, train, and setup career development goals and conduct performance reviews for staff. + Create and report infrastructure qualification metrics to Sr management + Embody Thermo Fisher's 4i values: integrity, innovation, intensity, and involvement + Align with company's Global IT Policies & Procedures How will you get there? Experience: + Must have a minimum of 6 years of experience in a leadership role + Minimum of 3 years of experience working in GAMP 5, validation and/or infrastructure qualification in a regulated industry + Functional understanding of IT infrastructure including basic networking, server operating systems, and Active Directory group policy objects + Must have people management experience with consistent track record of managing dedicated teams + Proven affinity and understanding of quality, regulatory and compliance standard methodologies + Proven IT leadership and project management skills + Proficiency with regulations related to GxP and use of computerized quality management systems + 3+ years of experience leading a team of IT professionals in an FDA regulated (GXP), fast-paced, large company environment Education: + Minimum of Bachelors degree, or Master's degree in Computer Science, MIS, IT, Business, Accounting or other related IT field + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Knowledge, Skills, Abilities + Knowledge of concepts, components, terminology related to cybersecurity, information security and/or networking + Understanding of IT governance, ITIL or COBIT + Able to work in a multi-disciplinary and geographically dispersed team + Able to prioritise multiple projects, deliverables, and customers + Proven track record in working in an FDA regulated (GXP), fast-paced, large company environment + Ability to share technical competencies with others and to apply this knowledge to assist in issue 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 + 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. + AWS certifications preferable Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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