Sr Manager, Information Technology

Business partnership and technology expertise

• Focus will be business relationship, program, systems development and group management across the Development and Quality organizations
• The Ideal candidate will have demonstrated experience in laboratory, quality, and business process and systems leadership as it relates to compliance with regulatory and corporate expectations and guidelines
• The ideal candidate will be able to demonstrate a successful track record of assessing systems against corporate and regulatory requirements and driving change to ensure compliance in a GxP environment
• The ideal candidate will possess a fundamental understanding of computer applications, hardware, laboratory equipment/testing and supported processes utilized in a GxP biopharmaceutical company
• The ideal candidate will be able to demonstrate a successful track record developing processes, SOP’s, systems to support applications and equipment in a GxP environment
• Results oriented information systems leader with a strong track record of people leadership and project delivery excellence.
• Serve as both tactical and strategic IT liaison to the business through building and fostering a partnership
• Provide recommendations to address and resolve business issues, improve business processes and leverage opportunities
• Demonstrate strong understanding of data integrity, quality, and change management processes in a GxP, regulated environment.
• Strong understanding of the Quality, Mfg, Regulatory and/or Supply Chain business areas and their supporting technology as well as broad understanding of overall business units a plus
• Be point of contact for business focused application questions and be able to identify and leverage resources across IT
• Develop global strategies addressing ambiguous issues, large and diverse in scope.
• Drive organizational improvements in areas of lean business process and information systems.

Impact

• In collaboration with the business customer, utilizes broad business knowledge to proactively search for strategic technological solutions
• Exerts some influence on the overall objectives and long-range goals of the business area
• Builds and manages peer and management-level business relationship through achievement of results, accountable to schedule, and allocation of resources and meeting customer needs

Business relationship management and solution delivery

• This is not a project/program management role but the ideal candidate must be able to demonstrate a successful track record for collaboration with teams and influencing colleagues to drive initiatives to a successful conclusion
• Ensure solution delivery meets business need and expectation through business requirement gathering
• Partner with business clients and solution delivery team to determine appropriate solutions
• Plan and organize tasks, report progress, and manage and coordinate with consultants for implementations
• Gather and validate business needs to translate into requirements for technical team
• Work with technical teams to develop technical requirements and solutions
• Plan and execute change management activities

Scope

• Collaborates cross functionally to driver initiatives to a successful conclusion
• Processes/projects may have cross functional impact
• Focused on one or more functional areas/processes; has knowledge of cross functional areas/processes and related impact
• Works within defined budgets to exercise financial adherence at the project level
• Execute and/or manage the execution of unit, functional and user testing

Decision Making

• Performs work without appreciable direction
• Exercises considerable independence in determining objectives and approaches to assignment
• Draws from past experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovativeness within the boundaries of industry compliance regulations
• Identifies and recommends process improvements
• Decisions are made independently with a high degree of initiative
• Demonstrates ability to identify issues, independently resolves routine issues, escalates more complex issues to a higher level

Knowledge

• In depth knowledge of business functional area with strong understanding of business unit (Or if new to business area, shows strong learning agility to achieve in depth knowledge)
• Facilitate business requirements gathering process through best practices
• Understands the technology offerings applicable to the business when assisting in the design of solutions
• Has knowledge of and utilizes software lifecycle methodologies
• Demonstrates basic project management skills, systems analysis skills, meeting facilitation and documentation skills

Liaison

• Primary interaction is with members across business department(s) in functional area or a complex business department they support
• Regularly communicates findings, data, and status to clients and/or management, and external vendors
• Ability to articulate complex technical problems and solutions to a wide audience
• Communicate issues and risks directly to client and IT management
• Represents business department/area as the IT liaison on projects and initiates technical capabilities/opportunities

5 Years relevant experience

Demonstrated knowledge of GxP, Data Integrity, Systems Compliance and other regulations relevant to Quality Systems Management

Audit preparation experience in a GxP environment

Life Sciences biotech/pharmaceutical experience

GxP validated systems experience

Education

BS/BA required in Life Sciences or IT related Discipline

Relevant industry certification or training (if applicable)

Additional Information

All your information will be kept confidential according to EEO guidelines.