Senior Manager, Quality Engineering
Core
Leads a Quality Engineering team to support manufacturing processes, ensuring compliance with AbbVie Quality Systems, cGMP, and regulations across product, process, equipment, and facility activities.
Role type
Senior Manager, Quality Engineering
Builds
Manufacturing process quality oversight, validation, qualification, and compliance activities
Domain
Pharmaceutical manufacturing / Life Sciences
Deliverable
client delivery
Required skills
Quality engineering expertise, validation and qualification strategy, risk-based compliance decision making, team leadership and development, budget management, statistical quality systems, electronic document management, laboratory information management, cGMP and regulatory knowledge, people management
Preferred skills
Strategic vision for team building, cross-functional collaboration and negotiation, influence across diverse teams
Technologies
Electronic document management systems, Laboratory information management systems
Responsibilities
Lead and develop a team of quality engineers; Provide functional leadership for quality engineering activities; Ensure validation and qualification strategies are executed per regulations; Review quality and compliance gaps and drive risk-based actions; Partner with Manufacturing, Validation, Engineering, and Regulatory teams; Guide risk management activities; Ensure quality engineering issues are identified and resolved; Communicate status, risks, and trends to management.
Seniority
Senior, hands-on IC with leadership
