Senior Manager, Third Party Quality - FSP

This is a fully remote position, open to applicants in Canada.

📋 Description

• Assess, analyze, and address GCP quality risks associated with vendor and site collaborations.

• Facilitate quality discussions with major vendors and sites, delivering quality insights at pertinent oversight meetings.

• Generate quality oversight reports for relevant sponsor management and functions.

• Disseminate essential quality information (e.g., findings from inspections/audits) among vendors and site entities, serving as the quality expert for third parties.

• Validate, monitor, and resolve GCP quality-related action plans.

• Evaluate quality performance at the enterprise level to enhance the continuous improvement of quality risk management.

• Advise the site organization relationship owner on considerations for quality enhancement.

• Assist Vendor Leads/Business Owners in ensuring adherence to functional level vendor oversight standards.

⛳️ Requirements

• BS with 7+ years of experience or equivalent.

• MS/MBA with 6+ years of experience or equivalent.

• At least 5 years in the pharmaceutical industry with extensive experience in clinical trial development.

• Comprehensive knowledge in quality domains (including audit, inspection, compliance, and inspection readiness).

• Quality-related experience that encompasses working knowledge in:

• o Quality and compliance management, QC.

• o Root Cause Analysis.

• o Risk identification, controls, mitigations, and actions.

• o Metrics development and utilization.

• o Conducting audits and inspections, along with the CAPA response process.

• Capability to develop strategies utilizing coordinated and transparent metrics for tracking and managing compliance.

• Ability to engage in cross-line global initiatives or root cause analysis for improvements in quality-related processes.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.