Lead root cause investigations and CAPA in office in Mississauga, applying data-led quality expertise within a major pharmaceutical company.
Alphanumeric seeks a Senior Manager for Root Cause Investigation and Corrective and Preventive Action activities. You will support research and development and related functions while partnering with quality, safety, clinical, and regulatory teams. The work focuses on complex issues, risk reduction, and practical solutions.
Key Responsibilities:
- Lead end-to-end investigations for cross-functional, high-risk issues
- Coach colleagues on investigation tools and risk assessment
- Design and support SMART corrective and preventive actions
- Oversee CAPA closure and effectiveness implementation
- Monitor signals and facilitate management review and oversight
Requirements:
- Advanced degree or equivalent experience in a relevant discipline
- Training or certification in root cause analysis, Six Sigma, or Lean
- About four years of root cause investigation experience ideally
- Pharmaceutical, vaccines, or life sciences quality experience
- Experience with GCP, GVP, and/or GLP
Apply pharmaceutical quality leadership, structured investigation, and CAPA expertise to complex regulated issues in Mississauga.