Senior Manager - Pharmaceuticals RCI & CAPA

About the role

A pharmaceutical company based in Mississauga, Ontario, is hiring a Senior Manager for Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) through Alphanumeric Systems. The role leads RCI and CAPA activities across research and development and related functions, working closely with quality, safety, clinical and regulatory teams to resolve complex issues and reduce future risk. It is an on-site position in Mississauga, with occasional hybrid flexibility.

Key responsibilities

• Lead end-to-end root cause investigations for cross-functional and high-risk issues, using structured methods to reach evidence-based conclusions.
• 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.

Required profile

• Advanced degree (MSc, PhD or equivalent) in a relevant discipline such as life science, engineering, quality, or equivalent experience.
• Formal training or certification in root cause analysis, Six Sigma, Lean or similar methodologies.
• Ideally about 4 years of root cause investigation and 4 years of clinical development / GCP experience.
• Significant experience in issue investigation, CAPA management, quality or risk roles in pharmaceutical, vaccine or life sciences settings.
• Demonstrated experience leading root cause analyses and implementing CAPAs in a regulated environment.
• Proven ability to influence across a matrix organisation and lead cross-functional teams.
• Must be based in Canada with valid documentation (PR or valid work permit and valid SIN).

Required skills

• GCP, GVP and/or GLP experience.
• Strong knowledge of quality management systems and applicable regulatory expectations.
• Comfortable working in a hybrid model with regular on-site presence.

What we offer

• Salary of 49 CAD per hour.
• One-year contract with a high possibility of extension.
• Monday to Friday, 9am to 5pm EST (standard business hours).
• Start date at the end of November.