Senior Manager, Third Party Quality - FSP

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

📋 Description

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

• Facilitate quality discussions with key vendors and sites, presenting the quality perspective at relevant oversight meetings.

• Deliver quality oversight reports to the appropriate management functions and sponsors.

• Disseminate essential quality information (e.g., inspection/audit learnings) across vendors and site entities, acting as the quality expert for third parties.

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

• Assess quality performance at an enterprise level to guide continual enhancement of quality risk management.

• Advise site organization relationship owners on quality improvement considerations.

• Assist QMS09 BPO in the creation and execution of process updates.

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

⛳️ Requirements

• Bachelor's degree with 7+ years of relevant experience or equivalent.

• Master's degree/MBA with 6+ years of pertinent experience or equivalent.

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

• Strong understanding of quality domains (e.g., audit, inspection, compliance, and inspection readiness).

• Experience related to quality, encompassing knowledge in:

• o Quality and compliance management, QC.

• o Root Cause Analysis.

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

• o Development and usage of metrics.

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

• Capability to develop strategies using coordinated and transparent metrics for compliance tracking and management.

• Ability to engage in cross-line global initiatives or root cause analysis aimed at quality-related process improvements.

🏝️ Benefits

• Health insurance.

• 401(k) retirement plans.

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.