Senior Manager Quality Assurance – Major Deviations Lifecycle Team
Core
Leading the Major Deviations Team to ensure timely, compliant, and effective management of significant quality events across manufacturing, packaging, laboratory, and support operations.
Role type
Senior Manager, Quality Assurance (Major Deviations Lifecycle)
Builds
Robust deviation investigations, root cause analyses, risk assessments, and corrective/preventive actions (CAPAs) to ensure product quality and patient safety.
Domain
Pharmaceutical/Biotechnology Manufacturing and Quality Systems
Deliverable
client delivery (regulatory compliance and inspection readiness)
Required skills
Strategic oversight of deviation investigations, root cause analysis, risk assessment, CAPA execution, team leadership, cross-functional collaboration, regulatory compliance management, data integrity management, continuous improvement, resource planning, audit support.
Preferred skills
Life Science or Engineering background, cGMP regulations knowledge, electronic quality systems expertise, data-trending tools, inspection readiness leadership, cross-functional team leadership in regulated environments.
Technologies
Digital quality management systems (DQMS), electronic quality management systems, data-trending tools.
Responsibilities
Lead and manage the Major Deviations Team including performance management and resource planning; Provide oversight for complex deviation investigations and root cause analyses; Ensure deviations are initiated, investigated, and closed within quality timelines; Drive effective root cause analyses using structured methodologies; Maintain accountability for accurate documentation and CAPA execution; Escalate critical quality issues to leadership; Collaborate with cross-functional teams to implement sustainable corrective actions; Monitor deviation trends and quality metrics; Support internal and regulatory audits; Ensure compliance with cGMP and global quality standards; Lead major deviation improvement programs; Participate in governance forums and quality councils.
Seniority
Senior, hands-on IC with strategic oversight and team leadership
