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Alphanumeric Systems

Senior Manager RCI & CAPA - Clinical development/GCP experience

Mississauga, ON, Canada

$49 CAD / hour · Contract

Apply on alphanumeric-systems.breezy.hr About employer

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Job details

Pay: $49 CAD / hour
Job type: Contract
Experience: Ideally about 4 years of Root cause investigation and 4 years of Clinical development /GCP experience.
Posting language: English
Posted: Oct 21, 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: 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.

Apply on alphanumeric-systems.breezy.hr About employer

More about this job

Responsibilities

Lead end-to-end root cause investigations for high-risk issues and oversee the implementation of corrective and preventive actions. Partner with cross-functional stakeholders to simplify workflows, improve issue management practices, and ensure regulatory compliance.

Requirements

Requires an advanced degree in a relevant life science or engineering field and formal training in root cause analysis methodologies. Candidates should have approximately four years of experience in root cause investigation and clinical development within a regulated pharmaceutical environment.

Skills

Root Cause Investigation
CAPA Management
Clinical Development
GCP
GVP
GLP
Quality Management Systems
Risk Assessment
Six Sigma
Lean
Regulatory Compliance
Cross-functional Leadership
Data-led Solutions
Stakeholder Management
Issue Investigation

Visa sponsorship

Not detected in the job text

Keywords

Root Cause Investigation
CAPA
Clinical Development
GCP
GVP
GLP
Pharmaceutical
Life Sciences
Quality Management Systems
Six Sigma
Lean
Risk Assessment
Regulatory
Compliance
Matrix Organization
Data-led
SMART CAPA
Management Review
Signal Monitoring
Process Improvement

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