Precision Life Sciences
The Senior 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 Senior 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 Senior Director, IT Systems reports to the VP, IT.
- 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.
- Conduct analysis and recommend business strategic solutions to improve technical processes.
- 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.
- Lead and maintain IT roadmaps in alignment with business requirements.
- 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 and 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.
- Conduct periodic assessments of business processes.
- Develop and execute a strategy for the management of legacy data, documentation, and other regulated content.
- Establish and implement a validated systems approaches for GxP data.
- Provide excellent project management knowledge and skills.
- 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 8 years’ experience in IT Quality and Compliance oriented roles.
- Minimum of 5 years’ experience in validating regulated products.
- Hands-on experience documenting policies and procedures in a regulated, pharmaceutical, environment.
- Deep experience and working knowledge of Quality, R&D, Clinical, and Compliance systems.
- Knowledge of key regulations and practices surrounding GxP, and how they impact technology definition, development, validation, implementation, maintenance, and administration.
- 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, project management, 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 1-2 days per week.
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