IT Validation Manager
Provide expertise, leadership and guidance to AbbVie Operations IT, on software life cycle management and validation. Share expertise and best practices with Quality, Manufacturing, and Supply Chain application validation Key Responsibilities Include:
- Provide Leadership to the Validation team in the execution of risk-based validation strategies
- Guide and advise Operations IT and Business stakeholders, to leverage risk-based validation approaches, minimizing cost and schedule
- Represent Operations IT on cross-functional councils and teams.
- Interpret and communicate quality and compliance requirements from regulations and from policies, processes, procedures, and guidelines that impact GMP systems.
- Establish partnerships with IT and SQA leadership, sharing knowledge and identifying approaches that benefit Operations business partners.
- Contribute to Compliance metrics, conveying Validation activities and improvement opportunities.
- Establish goals for global strategic validation initiatives, collaborating with other cross-functional organizations as needed.
- Develop software validation improvement strategy and implement strategy through action plans; implement validation process improvements.
- Demonstrate accountability for development and improvement of Operations validation standards and operating model.
- Coordinate projects between IT areas, clients, and vendors. Provide leadership to overcome obstacles and challenges.
- Foster employee development, enabling employees to grow in their roles and contribute to the organization in greater capacities.
- Must have a sound technical background in computer science and general business.
- Minimum 6+ years of system development life cycle and/or validation life cycle experience.
- Minimum 3+ years of Project Management related experience.
- Minimum 3+ years of supervisory/managerial experience.
- Bachelor's degree required, Computer Science, Management Information Systems or related focus of study preferred.