Senior Quality Manager

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

📋 Description

• Provides oversight on functional and project-level quality across the designated scope.

• Ensures adherence to GCP and other relevant GxP regulations.

• Supports and engages in eQMS lifecycle activities, including necessary validation oversight activities.

• Oversees and conducts vendor quality management tasks, such as qualification, risk assessment, and RFIs; reviews and approves outputs produced by Quality Managers.

• Assists business units and clients with projects, including the development and upkeep of project-specific quality frameworks and procedures.

• Creates, reviews, and endorses controlled documents; ensures consistency, regulatory compliance, and alignment with the QMS.

• Manages quality issues and CAPAs, including oversight of investigations, escalation of significant risks or delays, and decision-making on critical matters and suspected serious breaches.

• Engages in quality risk management initiatives, including risk identification, assessment, and review.

⛳️ Requirements

• Bachelor's degree in Life Sciences or equivalent experience.

• Over 5 years of experience in quality management/QA.

• More than 5 years in GxP auditing is a plus.

• Strong knowledge of GCP/GxP, QMS, and system validation.

• Demonstrated ability to work independently and lead complex quality initiatives.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunity for personal and professional growth.