Posted 23 days ago
Senior Manager RCI & CAPA - Clinical development/GCP
@ Alphanumeric Systems
Mississauga, Ontario
Overview
Alphanumeric Systems is hiring a Senior Manager for Root Cause Investigation and CAPA on contract in Mississauga, ON, for a large pharmaceutical company. The role leads cross-functional investigations and CAPA closure across R&D, with on-site work mainly and occasional hybrid flexibility. Pay is 49 CA$/hour, Monday to Friday 9am to 5pm EST, one year with likely extension, starting end of November; candidates must be based in Canada with valid work documentation.
Pay:
$49 an hour
Responsibilities:
- Lead end-to-end root cause investigations for high-risk issues
- Coach colleagues on investigation tools and SMART CAPA design
- Oversee CAPA closure and effectiveness
- Partner with process owners to reduce recurrence
- Facilitate management review and assess issue criticality
Requirements summary:
- Advanced degree in life science, engineering or quality
- Root cause analysis or Six Sigma/Lean certification
- About 4 years root cause investigation experience
- About 4 years clinical development or GCP experience
- Experience leading RCAs and CAPAs in regulated settings
- Ability to influence across a matrix organisation
Tools & skills
Source and dates
Employer career site / ATS feed · breezy
- Employer posting date
- 2026-10-20
- First seen by our source
- 2026-10-21
- Source record updated
- 2026-11-10
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Senior |
| Department | Quality assurance |
| Experience | 4+ years |
| Hours per week | 40 |
| Schedule | day |
| Travel | air: none · ground: none |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
| Education | Master’s degree (preferred), Doctorate (preferred) |
| Fields of study | life sciences, engineering, quality |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Alphanumeric Systems
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Full company description
At Alphanumeric, we are committed to bridging the gap between pharmaceutical companies, healthcare professionals (HCPs), patients, and caregivers through innovative and tailored communication solutions. Our mission is to enhance education, understanding, access, and loyalty by revolutionizing the way stakeholders in the healthcare ecosystem connect and collaborate. We empower pharmaceutical companies with personalized communication strategies that foster meaningful engagement, ensuring that critical medical information is delivered effectively, efficiently, and with clarity. By integrating cutting-edge technology and data-driven insights, we create bespoke solutions that drive improved patient adherence, better health outcomes, and stronger partnerships across the industry. Our expertise lies in developing tailored strategies that align with the evolving needs of healthcare providers and patients alike. We specialize in crafting communication pathways that break down barriers, ensuring seamless information flow that enhances treatment access, patient support, and HCP education. Whether through digital engagement platforms, omnichannel outreach, or real-time insights, we enable our partners to navigate the complex healthcare landscape with confidence. At Alphanumeric, we don’t just facilitate communication—we transform it. By fostering trust, accessibility, and engagement, we are shaping the future of healthcare interactions, ensuring that every message delivers value, every connection drives impact, and every stakeholder benefits from a truly integrated approach to healthcare communication. Together, we are not just enhancing communication—we are revolutionizing the way healthcare connects.
- LinkedIn followers
- 85,073
- People associated on LinkedIn
- 438
- Reported office locations
- 4515 Falls of Neuse Road, Ste 250, Raleigh, NC 27609, US
- 1000 Great West Road, Brentford, TW8 9HH, GB
- 201 King of Prussia Rd, Radnor Township, Pennsylvania, US
- #240-1050 Côte du Beaver Hall, Montreal, QC H2Z 1S4, CA
- Plac Andersa 7, 1st Floor, Poznan, 61-894, PL
- Nucleo Central – Tagus Park, Room 273, Oeiras, 2740 – 122, PT
- Unit 1612 Ayala Tower One, 6767 Ayala Avenue, Makati City, 1226, PH
- Calle Londres, Num. 43, Planta at, Puerta 4, Barcelona, 08029, ES
- 2300, Alameda Santos, Conj 11 parte,, Cerqueira Cesar, Sao Paulo, SP, 01418200, BR
- Calle 84 A 10 – 50, Piso 5, Bogotá, D.C., 110221, CO
- Noida, IN
- Business categories
- Software
- Internet
- Pharmaceutical
- Other recorded names
- Alphanumeric Systems
- Specialties
- Managed Services
- Professional Services
- Staffing Services
- Service Desk
- Contact Center
- Intelligent Automation
- Artificial Intelligence
- Automation
- Innovation
- Help Desk
- customer experience
- patient support
- clinical trials
- patient experience
- product launch
- patient adherence
- Pharmacovigilance
- localization
- Medical Communications
- Omnichannel
- Learning and Development
- and regulatory writing
- Profile identifies a recruitment agency
- No
- Reported total investment
- 0
Currency and observation date were not supplied; this is not a current valuation or a funding round.
At Alphanumeric, we are committed to bridging the gap between pharmaceutical companies, healthcare professionals (HCPs), patients, and caregivers through innovative and tailored communication solutions. Our mission is to enhance education, understanding, access, and loyalty by revolutionizing the way stakeholders in the healthcare ecosystem connect and collaborate. We empower pharmaceutical companies with…
| Field | Value |
|---|---|
| Industry | Pharmaceutical Manufacturing |
| Company size | 201-500 employees |
| Headquarters | Raleigh, NC |
| Organization type | Privately Held |
| Year founded | 1979 |
| Specialties | Managed ServicesProfessional ServicesStaffing ServicesService DeskContact CenterIntelligent AutomationArtificial IntelligenceAutomationInnovationHelp Desk |
| Open jobs on Jobsy | 6 |
| View page |
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.
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