Senior Quality Lead – FSP

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

📋 Description

• Identify, assess, and address GCP quality risks associated with vendor and site interactions.

• Facilitate quality discussions with key vendors and sites, providing a quality perspective in relevant oversight meetings.

• Deliver quality oversight reports to the appropriate management/functions of the sponsor.

• Share essential quality information (e.g., findings from inspections/audits) across vendor and site entities, acting as a quality expert for third parties.

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

• Evaluate quality performance at an enterprise level to support the ongoing improvement of quality risk management.

• Notify the site organization relationship owner of considerations for quality improvement.

• Assist QMS09 BPO in developing and implementing process updates.

• Aid Vendor Leads/Business Owners in ensuring adherence to functional vendor oversight requirements.

⛳️ Requirements

• BS with 7+ years of experience or equivalent.

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

• At least 5 years of experience in the pharmaceutical sector, with substantial involvement in clinical trial development.

• Strong knowledge in quality domains (such as audits, inspections, compliance, and readiness for inspections).

• Experience related to quality, including practical knowledge in:

• o Quality and compliance management, QC.

• o Root Cause Analysis.

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

• o Development and use of metrics.

• o Conducting audits and inspections and managing the CAPA response process.

• Capacity to devise strategies using coordinated and transparent metrics for tracking and managing compliance.

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

🏝️ Benefits

• Health insurance.

• Flexible working arrangements.

• Opportunities for professional development.