Senior Manager (GCP) - Pharmaceuticals RCI & CAPA

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

Job summary

Alphanumeric Systems in Mississauga, Ontario, is hiring a Senior Manager for Root Cause Investigation (RCI) and CAPA to lead investigations across R&D and related functions on-site. You will collaborate with quality, safety, clinical and regulatory teams to resolve complex issues and reduce future risk, driving data-led solutions with practical impact.

The role requires an advanced degree and formal training in RCA or Six Sigma, with roughly four years in RCA and clinical development/GCP, plus

Qualifications

• Advanced degree in life science, engineering or related field.
• Formal training/certification in root cause analysis, Six Sigma, Lean or similar.
• About 4 years in RCA and 4 years in Clinical development / GCP.
• Significant experience in CAPA, quality or risk roles in pharma settings.
• GCP, GVP and/or GLP experience.
• Proven ability to lead RCA and implement CAPAs in regulated environments.
• Strong knowledge of quality management systems and regulatory expectations.
• Ability to influence across a matrix organisation and lead cross-functional teams.
• Hybrid/work-on-site with regular on-site presence.

Responsibilities

• Lead end-to-end RCA for cross-functional, high-risk issues with evidence-based conclusions.
• Coach colleagues on investigation tools, risk assessment and SMART CAPA design.
• Oversee CAPA closure and effectiveness implementation.
• Partner with process owners to simplify workflows and reduce recurrence.
• Facilitate management review and monitor signals and performance.
• Assess issues for criticality.

Skills

Root Cause Analysis

CAPA Management

GCP/GVP/GLP knowledge

Cross-functional leadership

Quality management systems

Regulatory awareness

Education

MSc or PhD

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 biggestPharmaceutical 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.

Pleasebe aware that we can only hire peoplealready based in Canadawith fully legaland valid documentation to work in Canada.

Conditions:

• Salary: 49 CA$/hour
• Employment: 1 yearwith high possibility of extension
• WorkingHours: Monday to Friday - 9am to 5pm EST (Standard BusinessHours)
• Type of Work: On-site mainly, with occasional hybrid flexibility
• Location: 100Milverton Drive, Mississauga, ON
• Start date: end of November
• Mandatoryto 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.

Maintasks 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.