The Sr Manager, IT Quality Assurance is responsible for providing quality assurance oversight for software validation activities. This role will support the strategic direction to ensure business objectives are met. This position ensures that defined software validation practices and procedures are being followed. The Senior Manager, IT Quality Assurance will manage a team of quality professionals with quality assurance accountability for regulated IT systems within Information Research/ R&D.
- Manage a team of Quality professionals who assure regulated applications for a Information Research/ R&D are implemented and maintained in accordance with AbbVie’s System Lifecycle (SLC) process.
- Ensure software quality assurance is achieved during IT projects while meeting project objectives and deliverables; review validation deliverables to ensure consistency with defined practices and procedures.
- Oversee validation support to project managers regarding activities supporting existing applications in all phases of the System Development Life Cycle process.
- Manage the integration of new validation technologies, processes, and quality assurance practices within an AbbVie Information Research/ R&D.
- Initiate process improvements to reduce validation costs and cycle time.
- Defend AbbVie IT practices and system qualification and validation documentation to Federal and international regulators during inspections and audits.
- Relationship Management: Establish and maintain high-quality relationships with all levels across the company and with external partners.
- Responsible for all aspects of people leadership; setting expectations, coaching, counseling, developing, evaluating, feedback, hiring, discipline and separations. Confront and resolve employee issues in a constructive and timely manner. Responsible for overall morale of team.
- Build a high performing team with depth and breadth of knowledge.
- Excellent communication skills and able to deal constructively with conflict.
- Bachelor's Degree with 8 years’ experience. Preferably a BS in Computer Science, Engineering, or another technical discipline.
- 8 years of experience in a formal software development lifecycle with at least 5 years in a GxP software environment.
- 3 years of experience leading teams.
- 3-5 years’ experience in a regulated software development / validation environment, leading software validation efforts or providing software quality assurance support and managing teams.
- Knowledge of regulations and standards that affect the health care industry
This position is part of AbbVie’s Information Security & Risk Management (ISRM) team. We are here to put our partners in a position to succeed. We do it by providing the knowledge, tools, and support they need to effectively use data and technology while also effectively managing risk.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.