Manager, Quality Systems and Risk Management

What You'll Do
- Support execution and continuous improvement of the organization’s risk management program and Quality Management System (QMS).
- Lead formal risk management (risk assessments, risk registers) using ICH Q9 and FMEA frameworks.
- Maintain and improve the QMS, including onboarding/implementation of new Veeva Vault QMS modules and maintaining associated documentation.
- Manage APQR report preparation/compilation; support cross-functional data collection and ensure timely completion/approval.
- Generate quality metrics and KPIs for Quality Management Reviews (QMRs); analyze/present quality data and collaborate with stakeholders.
- Assist with Lean Six Sigma process improvement (data gathering, root cause analysis support, CAPA follow-through).
- Participate in audits and regulatory inspections.
- Ensure compliance with GxP regulatory standards and internal procedures.
- Prioritize work to meet targets/timelines; assist with SOP preparation/revision.

Responsibilities
- Own and drive risk management activities and serve as SME for risk methodology.
- Support QMS improvement initiatives and procedural ownership of assigned QMS processes.
- Escalate potential trends and product quality/regulatory compliance issues.

Qualifications/Required
- Bachelor’s degree (pharmacy, science, mathematics, or engineering).
- 8+ years’ experience in biotech/pharmaceutical FDA-regulated industry in QA or related field.

Skills/Preferred
- Strong GxP risk management leadership (FMEA, risk ranking, ICH Q9).
- Knowledge of Lean Six Sigma.
- Knowledge of regulatory requirements (e.g., FDA, ICH, EU GMP, GDP).
- eQMS proficiency (preferably Veeva), Microsoft Office/Excel/Docs.
- Experience with commercial marketed products.

Compensation/Benefits (if part of posting)
- Salary (CA): $126,400–$152,700 USD.