Senior Manager (RCI-CAPA)

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

Job summary

Alphanumeric is seeking a Senior Manager for Root Cause Investigation and CAPA in Mississauga, ON. The role focuses on leading investigations across R&D and related functions, collaborating with quality, safety, clinical and regulatory teams to resolve complex issues and reduce future risk.

The position requires an advanced degree and formal training in root cause methodologies, with a preference for 4+ years in RCI and clinical development/GCP experience.

Qualifications

• Advanced degree (MSc, PhD or equivalent) in a relevant discipline (life science, engineering, quality, or related field)
• 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 within pharmaceutical, vaccines, or life sciences settings
• Experience in GCP, GVP and/or GLP
• Demonstrated experience leading root cause analyses and implementing CAPAs in a regulated environment
• Strong knowledge of quality management systems and applicable regulatory expectations
• Proven ability to influence across a matrix organisation and lead cross-functional teams
• Comfortable working in a hybrid model, with an expectation to be on-site regularly

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

Skills

Root cause analysis

CAPA management

GCP

GVP

GLP

Six Sigma

Lean

Quality management systems

Cross-functional leadership

Matrix leadership

Education

MSc/PhD or equivalent

Job description

Alphanumeric is hiring a Senior Manager for Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) to work on-site in Mississauga, ON, for one of the biggest Pharmaceutical companies in the world, based in Mississauga, Ontario.

You will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development and related functions. You will work closely with quality, safety, clinical and regulatory to resolve complex issues and reduce future risk. We value clear thinkers who listen, influence with empathy, and drive practical, data-led solutions. This role offers visible impact, real career growth and the chance to shape processes that help us unite science, technology and talent to get ahead of disease together.

Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada.

Conditions:

• Salary: 49 CA$/hour.
• Employment: 1 year with high possibility of extension.
• Working Hours: Monday to Friday – 9am to 5pm EST (Standard Business Hours).
• Type of Work: On-site mainly, with occasional hybrid flexibility.
• Location: 100 Milverton Drive, Mississauga, ON.
• Start date: end of November.
• Mandatory to be based in Canada with valid documentation (PR or valid Work Permit + valid SIN).

Requirements:

• Advanced degree (MSc, PhD or equivalent) in a relevant discipline (life science, engineering, quality, or related field, 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 within pharmaceutical, vaccines, or life sciences settings.
• Experience in GCP, GVP and/or GLP.
• Demonstrated experience leading root cause analyses and implementing CAPAs in a regulated environment.
• Strong knowledge of quality management systems and applicable regulatory expectations.
• Proven ability to influence across a matrix organisation and lead cross-functional teams.
• Comfortable working in a hybrid model, with an expectation to be on-site regularly.

Main tasks and 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.