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The Associate Director, IT Business Partner for GxP Systems will be a strategic technology partner supporting designated teams to align technology direction to business goals and needs. This role defines key processes and requirements, creates technology roadmaps, acts as subject matter authority for technology-related processes and systems, leads technology partners, ensures appropriate level of compliance, and provides technology leadership and project management for technological projects.
This role is responsible for the information technology strategic direction in partnership with functional leadership (Quality, Regulatory, Drug Safety, etc.) focusing on building out capabilities of existing platforms.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Partner with senior IT leadership in developing-an IT strategic plan for assigned client businesses and gain alignment on timing for investments on new business capabilities; ensuring that technology architecture, applications, processes, support operations and governance are aligned to strategic business initiatives
Finds opportunities where existing platform capabilities can align with IT strategy for functional leadership business goals
Lead efforts to ensure IT GxP compliance requirements are accurately assessed and implemented for both new solutions and improvements to existing systems
Partner with Quality systems validation and compliance resources
Lead external vendors to deliver complaint services and solutions on time and on budget
Lead the negotiation of requirements across multiple stakeholders and translate those requirements into functional requirements
Lead the prioritization of business deliverables to align with finite resources and/or business critical completion dates
Lead business case for IT investments and assist in preparation/presentation to business leaders and potentially the Executive Team
Support and improve SaaS solutions and on-premise solutions
Manage client business expectations ensuring they are being met through delivery of services or projects
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum of Bachelor’s degree in computer science or information systems or related field required with at least 10 years of IT experience in Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry (an equivalent combination of education and experience may be considered)
Experience with implementation of solutions with a focus on compliance GxP is required
Seasoned experience with IT Change Control to ensure GxP systems remain complaint thru support process
Demonstrated ability to partner with business team leaders and build alignment on technology investment
Experience with Quality, Regulatory and functions with GxP requirements
Lead and manage diverse IT resources to deliver business platforms
Demonstrated ability to successfully lead high-profile, sophisticated projects and implement third party solutions with minimum disruption to business
Experience with implementing, and enhancing Veeva’s technology platform; bring to bear Veeva’s various service offerings
Demonstrated ability to quickly adapt and apply new technical knowledge based on departmental and corporate goals and objectives, work successfully in cross functional teams, effectively identify problems, and develop flexible, scalable, and efficient solutions
Strong technical knowledge and practical experience in defining, implementing, and leading business and technical solutions
Strong written and oral communication skills, possessing the ability to communicate at both a technical level as well as at a business subject area level
Experience with technical implications of supporting GxP requirements
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC’s scanners, facsimile machines, voice mail and email systems and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Knowledge of technologies critical to biotech organizations including key technologies supporting Quality Management Systems, Regulatory Submissions, Information and Publishing, Drug Safety case management and reporting, Manufacturing/Supply Chain and Document Management
Veeva R&D platform
Oracle ARGUS safety platform
Experience with tools, technologies, and approaches to building, supporting and business reporting and analytics
INTERNAL AND EXTERNAL RELATIONSHIPS:
Manufacturing and Supply Chain
Establish close relationships with key solution vendors as well as technology services vendors to improve vendor service levels and responsiveness
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting to20lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:N/A
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