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Franklin Fitch
boston, ma
IT Infrastructure Director | Boston, MA (Hybrid) | $185,000-$215,000 + 25% Bonus A leading biotech firm is seeking an experienced IT Infrastructure Director who will be responsible for managing a 12-person IT team as well as taking ownership over their IT infrastructure across servers, networks, cybersecurity, and vendor management. It will be a 6
Job Source: Franklin FitchFranklin Fitch
Boston, MA, United States
Director, IT Infrastructure | Hybrid - Boston | 175 to 200k + Bonus Do you want to spearhead digital modernization projects within cloud services? Do you want to work for a company that will support your development and provide the opportunity to upskill with certificates? A leading biotech in the Boston area is on the hunt for a new senior mana
Job Source: Franklin FitchMIT
Cambridge, MA, United States
Director of Information Technology page is loaded Director of Information Technology Apply locations Cambridge, MA time type Full time posted on Posted 6 Days Ago job requisition id JR100153 Classification: Exempt Job Family: Senior Management Reports to: Vice President and COO Job Descripti
Job Source: MITFranklin Fitch
Cambridge, MA, United States
Senior Director of IT | Biotech | Hybrid, Cambridge MA | $180,000 - $280,000 depending on experience One of Boston’s leading biotech’s are looking to bring on board a Sr Director of IT Operations to join their growing team and guide the company on their exciting growth plans. The role provides you the opportunity to work for a growing company wit
Job Source: Franklin FitchPage Mechanical Group, Inc.
Boston, MA, United States
Director, Information Technology (IT) Systems TheDirector, Information Technology (IT) Systems will collaborate with the VP, IT to provide the strategic framework for validation, management, and support of GxP-regulated systems and implement against the strategy in collaboration with stakeholders. The Director, IT Systems will collaborate with Qu
Job Source: Page Mechanical Group, Inc.Generate Biomedicines, Inc.
Somerville, MA, United States
Working together toward limitless possibilities. We are differentiated in the composition of our team, which includes individuals from all areas— science, technology, and business —who share apioneering mindset, and are passionate about finding better ways to create medicines for patients. We seek diverse perspectives because we believe that eng
Job Source: Generate Biomedicines, Inc.Spencer Thomas
Boston, MA, United States
Position Overview: We are seeking an experienced HRIS Director. The HRIS Director will be responsible for leading and managing HRIS operations in a fast-paced and challenging environment. Responsibilities: Provide extensive knowledge of the UKG Pro platform Oversee and manage HRIS operations for the US and Canada, ensuring accuracy, efficiency, an
Job Source: Spencer ThomasAxcelis Technologies, Inc.
Beverly, MA, United States
Senior Director, Information Technology and Digital Transformation page is loaded Senior Director, Information Technology and Digital Transformation Apply locations Beverly, MA time type Full time posted on Posted 3 Days Ago job requisition id 10591 Essential Functions Manage the modernization and transfor
Job Source: Axcelis Technologies, Inc.Boston, MA, United States
TheDirector, Information Technology (IT) Systems will collaborate with the VP, IT to provide the strategic framework for validation, management, and support of GxP-regulated systems and implement against the strategy in collaboration with stakeholders.
The Director, IT Systems will work with Quality, R&D, Clinical, and Compliance stakeholders to map out short and long term strategies related to supporting the systems already in use or needed during the next 3-5 years. This includes procuring, validating, maintaining, and supporting these systems along with potentially migrating legacy content, where appropriate.
The Director, IT Systems reports to the VP, IT.
Job Responsibilities:
Partner with stakeholders providing SME guidance and support for Quality, R&D, Clinical, and Compliance systems.
Collaborate with teams regarding short and long term needs for Quality, R&D, Clinical, and Compliance systems.
Collaborate with teams to analyze and develop plans to streamline business process.
Collaborate with business to develop strategies for investigating, implementing, validating, and supporting new systems aligned to business requirements the next 3-5 years (eTMF, RIMS, SAP, etc).
Collaborate with business management and VP, IT on forecasting/budgeting.
Ensure proper validation, maintenance, and support of GxP regulated systems.
Ensure GxP systems adhere to computer systems validation processes and procedures.
Ensure documentation and policies are maintained. Systems and solutions are well documented, inventoried, and compliant with regulatory, technical, and operational standards, policies, and procedures.
Ensure change controls are strictly adhered to for regulated systems.
Establish and implement a validated systems approaches for GxP data.
Provide oversight to vendors/consultants providing systems or services support to GxP-regulated systems (e.g. Veeva) ensuring services provided are meeting/exceeding expectations.
Provide SME support to Quality Assurance for IT related audits (e.g. qualification/re-qualification audits).
Support regulatory compliance including SOX, CFR Part 11, GDPR, and others as required.
Staying updated on advancements in the fields of IT systems to advise businesses and clients on industry best practices.
Skills, Qualifications, and Requirements:
Bachelor of Science or comparable experience preferred.
Minimum of 5 years’ experience in IT Quality and Compliance oriented roles.
Minimum of 3 years’ experience in validating regulated products.
Deep experience and working knowledge of Quality, R&D, Clinical, and Compliance systems.
Hands on, working knowledge of Veeva platform required.
Excellent project management knowledge and skills.
Hands on experience documenting policies and procedures in a regulated, pharmaceutical, environment.
Extensive experience working cross-functionally, building collaborative working relationships and interfacing effectively with all levels of the business.
Good presentation skills in both the creation and delivery of presentations to large and small teams of people.
Excellent written and verbal communication skills.
Strong leadership, influencing, negotiation, and planning skills.
Ability to adjust quickly to changing priorities and conditions and to cope effectively with complexity and change.
Fosters a positive and collaborative work environment.
Willing to work in Boston 3 days per week.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com .
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Director, Information Technology jobs in Boston, MA, United States
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