Manager, QA & Continuous Improvement

About the Role

The Manager, Quality Assurance & Continuous Improvement is responsible for managing the Quality Assurance team across the function. This role oversees the Quality System, including owning and operating the Monthly Review Board (MRB), CAPA program, and managing all aspects of the Quality Monitoring program. It also maintains the documentation control system to ensure proper controls and accountability, supports internal and external audits, and drives the quality and continuous improvement strategy.

Responsibilities

• Manages the Quality Assurance team, including selection, hiring, setting performance expectations, and staff development.
• Assists with the development and implementation of the organizational Performance Improvement (PI) plan, including identifying PI goals, coordinating PI projects, and reporting activities and outcomes.
• Manages investigations (ERs), including oversight of complaints, non-conformances, CAPA, and deviations; identifies improvements and responds to trends.
• Manages quality and performance metrics and Key Performance Indicators (KPIs), utilizing trend and data analytics to prioritize areas of opportunity and drive improvements.
• Reviews and approves Quality System documents and records.
• Manages the organizational Risk Management process, partnering with OEC and BTS to improve privacy and security efforts.
• Supports internal and external audits, provides audit responses, and develops improvement plans based on audit feedback.
• Responsible for the monthly Management Review Board (MRB) meeting, collaborating with the quality team and larger organization to present quality trends, remediation efforts, and impact metrics.
• Oversees monitoring tools and supports the expansion of automated quality monitoring and analytics where appropriate.
• Supports other functional quality initiatives, programs, and systems as required.

Qualifications

• Bachelor’s degree in business, physical or life science, pharmacy, nursing, engineering, or a related field if combined with relevant work experience.
• 5+ years of experience in quality assurance, service center, or a technical field in a regulated industry or relevant experience.
• 3+ years of managerial and/or project management experience in quality assurance or a similar organization (highly desired).
• Knowledge of the AbbVie Quality System or similar, specifically governing policies and procedures related to Quality Assurance best practices.
• Experience driving key process improvement initiatives based on data-driven insights and Key Performance Indicators (KPIs).
• Ability to represent the Quality function effectively with senior managers, other AbbVie professionals, and external stakeholders.
• Strong communication skills and ability to collaborate effectively with stakeholders across the organization.
• Six Sigma, continuous improvement methodology, certification, or experience (preferred).
• Regulatory, compliance, and/or information security experience (desired).

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location. Individual compensation will be determined by factors such as qualifications and experience.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan for eligible employees.
• Eligibility to participate in long-term incentive programs.