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Senior Manager RCI & CAPA - Clinical development/GCP
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Alphanumeric Systems

Senior Manager RCI & CAPA - Clinical development/GCP

Mississauga, ON, Canada

Salary: 49 CA$/hour · Contract

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Job details

Pay: Salary: 49 CA$/hour
Job type: Contract
Apply by: Dec 10, 2026
Experience: Ideally about 4 years of Root cause investigation and 4 years of Clinical development /GCP experience.
Posting language: English
Posted: Nov 10, 2026

Original 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: Contractor
Duration: 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.

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More about this job

Responsibilities

Lead evidence-based root cause investigations for complex, cross-functional, and high-risk issues, and oversee CAPA design, closure, and effectiveness. Coach colleagues, partner with process owners to improve workflows and prevent recurrence, assess issue criticality, and support management oversight through proactive monitoring.

Requirements

An advanced degree in a relevant discipline or equivalent experience is required, along with formal training or certification in root cause analysis, Six Sigma, Lean, or a similar methodology. Candidates should have substantial investigation, CAPA, and quality or risk experience in a regulated life sciences setting, ideally including about four years each in root cause investigation and clinical development/GCP, plus strong regulatory, quality-system, and cross-functional leadership knowledge.

Skills

Root Cause Investigation
Corrective and Preventive Action Management
Clinical Development
Good Clinical Practice
Good Pharmacovigilance Practice
Good Laboratory Practice
Quality Management Systems
Risk Assessment
Six Sigma
Lean Methodologies
Cross-Functional Leadership
Regulatory Compliance
Issue Investigation
CAPA Effectiveness Monitoring
Management Review
Stakeholder Influence

Visa sponsorship

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Keywords

Root Cause Investigation
Corrective and Preventive Action
CAPA
Clinical Development
Good Clinical Practice
Good Pharmacovigilance Practice
Good Laboratory Practice
Pharmaceuticals
Vaccines
Life Sciences
Quality Management Systems
Regulatory Expectations
Risk Assessment
Issue Investigation
Six Sigma
Lean
Evidence-Based Analysis
SMART CAPA
CAPA Effectiveness
Management Review
Process Improvement
Cross-Functional Teams
Matrix Organization
Quality
Safety
Clinical
Regulatory

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