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MIT
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: MITPage 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.Quincy College
Quincy, MA, United States
Job Description: Position Summary: Quincy College is seeking a skilled IT Analyst to oversee and manage various IT operations, including asset management, security operations, network support, and help desk services. This position requires the successful candidate to manage and secure IT infrastructure across multiple campuses, with the availabili
Job Source: Quincy CollegeMarriott
Boston, MA, United States
Additional Information Dual Properties: Boston Marriot Copley & Sheraton Boston Hotel Job Number 23200604 Job Category Information Technology Location Sheraton Boston Hotel, 39 Dalton Street, Boston, Massachusetts, United States Schedule Full-Time Located Remotely? N Relocation? Y Position Type Management JOB SUMMARY Contributes general kn
Job Source: MarriottLineVision
Boston, MA, United States
Description We seek an Information Technology Lead to take broad ownership for delivering technologies and services to help employees stay productive, safe, and ISO 27001 compliant at our growing clean tech company. The successful Information Technology Lead , reporting to the Sr. Director of Security and IT, will embody the mindset of a servant
Job Source: LineVisionKate Farms
Waltham
Job Description Job Description ABOUT KATE FARMS Kate Farms is a company with heart. Our company was founded on the belief that good nutrition leads to good health, and good health opens the door to endless possibilities. That’s why our mission is to make nutrition the cornerstone of healthcare so people can live their best lives. We are a medi
Job Source: Kate FarmsMarriott
Boston, MA, United States
Additional Information Dual Properties: Boston Marriot Copley & Sheraton Boston Hotel Job Number 23200604 Job Category Information Technology Location Sheraton Boston Hotel, 39 Dalton Street, Boston, Massachusetts, United States Schedule Full-Time Located Remotely? N Relocation? Y Position Type Management JOB SUMMARY Contributes general knowledge a
Job Source: MarriottPlanned Parenthood League of Massachusetts
Boston, MA, United States
Care. No matter what: PPLM has been a leader in promoting sexual health formore than 90 years. We believe that all people deserve the information and expert services to make informed, personal decisions that affect their health, their lives and their futures. We are the state’s leading provider of sexual and reproductive health services. We educate
Job Source: Planned Parenthood League of MassachusettsBoston, 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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