Senior Manager RCI & CAPA - Clinical development/GCP experience
- Mississauga, ON, Canada
$49 CAD / hour · Contract
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Job details
- Pay
- $49 CAD / hour
- Job type
- Contract
- Apply by
- Experience
- Ideally about 4 years of Root cause investigation and 4 years of Clinical development /GCP experience.
- Posting language
- English
- Posted
Original job description
Alphanumeric is hiring a Senior Manager RCI & CAPA - Clinical development/GCP experience to work on-site in Mississauga, ON, for one of the biggest Pharmaceutical companies in the world, based in Mississauga, Ontario.
You will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development and related functions. You will work closely with quality, safety, clinical and regulatory to resolve complex issues and reduce future risk. We value clear thinkers who listen, influence with empathy, and drive practical, data-led solutions. This role offers visible impact, real career growth and the chance to shape processes that help us unite science, technology and talent to get ahead of disease together.
Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada.
Conditions
You will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development and related functions. You will work closely with quality, safety, clinical and regulatory to resolve complex issues and reduce future risk. We value clear thinkers who listen, influence with empathy, and drive practical, data-led solutions. This role offers visible impact, real career growth and the chance to shape processes that help us unite science, technology and talent to get ahead of disease together.
Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada.
Conditions
- Salary: 49 CA$/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).
- 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.
- 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.
More about this job
Responsibilities
Lead evidence-based root cause investigations for complex, high-risk issues and oversee CAPA design, closure, and effectiveness. Coach colleagues, partner with stakeholders to improve workflows and prevent recurrence, and monitor quality signals to support management oversight.
Requirements
Requires an advanced degree or equivalent experience in a relevant discipline, along with formal training or certification in root cause analysis, Six Sigma, Lean, or a similar methodology. Candidates should have substantial investigation and CAPA experience in regulated life sciences, ideally around four years each in root cause investigation and clinical development/GCP, plus strong quality-system knowledge and cross-functional leadership skills.
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
- Issue Investigation
- CAPA Effectiveness Monitoring
- Cross-Functional Leadership
- Stakeholder Influence
- Management Review
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Management & Leadership
- Science & Research
- Manufacturing
Keywords
- Root Cause Investigation
- Corrective And Preventive Action
- CAPA
- Clinical Development
- Good Clinical Practice
- Good Pharmacovigilance Practice
- Good Laboratory Practice
- Pharmaceutical Manufacturing
- Life Sciences
- Quality Management Systems
- Regulatory Expectations
- Risk Assessment
- Six Sigma
- Lean
- Issue Investigation
- CAPA Effectiveness
- Cross-Functional Teams
- Management Review
- Process Improvement
- Evidence-Based Analysis
- SMART CAPA
- Research And Development