Director, Information Technology (IT) Systems
The Director, 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 Quality, Pharmacovigilance, 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 will provide expertise, leadership, and collaboration with internal cross-functional teams, Managed Service Providers (MSPs) and Safety Service Providers (SSPs) ensuring overall excellence of AVEO vendor/partners performance through the delivery of skilled vendor management and project management.
The Director, IT Systems may assume other responsibilities as assigned by Management.
The Director, IT Systems reports to the VP, IT.
Job Responsibilities:
- Partner with stakeholders providing SME guidance and support for Quality, Pharmacovigilance, R&D, Clinical, and Compliance systems.
- Collaborate with teams regarding short and long term needs for Quality, Pharmacovigilance, R&D, Clinical, and Compliance systems.
- Collaborate with teams to analyze and develop plans to streamline business processes.
- Collaborate with stakeholders to develop strategies for investigating, implementing, validating, and supporting new systems aligned to business requirements the next 3-5 years (eTMF, Safety DB, RIMS, SAP, etc).
- Interface with MSPs/SSPs providing oversight and guidance.
- Collaborate with MSP/SSP Service Delivery Managers ensuring services are delivered to contractual agreements and support is expertly performed.
- Collaborate with MSP/SSP Project Managers for effective project management ensuring optimal performance.
- 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, policies, SOPs 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 approach for GxP data.
- Provide oversight to vendors/consultants providing systems or services in support to GxP-regulated systems (e.g. Veeva, Argus) ensuring services provided are meeting/exceeding expectations.
- Provide IT SME support for regulatory submissions.
- Provide IT SME support for audits (e.g. qualification/re-qualification audits).
- Support regulatory compliance including SOX, CFR Part 11, GDPR, and others as required.
- Stay 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 the biotechnology and/or pharmaceutical industry.
- Minimum of 3 years’ experience in validating regulated products.
- Deep experience and working knowledge of Quality, Pharmacovigilance, R&D, Clinical, and Compliance systems.
- Excellent project management knowledge and skills.
- Hands-on, working knowledge of Veeva platform required.
- Hands-on experience with safety databases, safety reports, aggregate reports, regulatory reporting, literature reviews, etc.
- Knowledge of MedDRA dictionary.
- 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.
- Experience managing vendor performance.
- 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.
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