Senior RCI & CAPA Leader — On-site Pharma Quality

Alphanumeric Systems Inc; Mississauga; On-site; CAD 56,000 - 79,000; Full time

Benefits offered by this job

Hybrid flexibility

Job summary

Alphanumeric Systems Inc. is hiring a Senior Manager for Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) to work on-site in Mississauga, ON, for a leading pharmaceutical company. Lead RCI and CAPA across R&D and related functions, coordinating with quality, safety, clinical and regulatory teams to resolve complex issues and reduce risk.

On-site with some hybrid flexibility. Role requires advanced degree in life sciences or related field, formal training in RCA/Six

Qualifications

• Advanced degree in life sciences, engineering, quality, or related field.
• Formal training in root cause analysis, Six Sigma, Lean or similar methodologies.
• Approximately 4 years of root cause investigation and 4 years of Clinical development /GCP experience.
• Experience in CAPA, quality or risk roles within pharmaceutical, vaccines, or life sciences settings.

Responsibilities

• Lead end-to-end root cause investigations for cross-functional and high-risk issues.
• Coach and support colleagues on investigation tools, risk assessment and SMART CAPA design.
• Oversee CAPA closure and effectiveness implementation.
• Partner with process owners and stakeholders to simplify workflows, reduce recurrence and improve issue management practices.
• Facilitate management review and oversight by proactively monitoring signals and business performance.
• Assess issues for criticality.

Skills

Root cause analysis

CAPA management

Team leadership

Cross-functional collaboration

Quality systems

Education

MSc/PhD or equivalent in life science/engineering/quality

Tools

Six Sigma

Lean

Job description

Alphanumeric Systems Inc. is hiring a Senior Manager for Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) to work on-site in Mississauga, ON, for a leading pharmaceutical company. Lead RCI and CAPA across R&D and related functions, coordinating with quality, safety, clinical and regulatory teams to resolve complex issues and reduce risk.

On-site with some hybrid flexibility. Role requires advanced degree in life sciences or related field, formal training in RCA/Six