Principal Quality Manager

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

📋 Description

• Oversees quality assurance for various projects, vendors, and systems, ensuring they are executed consistently and in compliance.

• Serves as the point of escalation for intricate, high-risk, or systemic quality challenges, inspection risks, and compliance issues within the designated scope.

• Directs complex investigations involving suspected serious violations, fraud, misconduct, and systemic quality concerns; ensures the development of effective CAPAs, conducts effectiveness checks, and performs trend analysis.

• Acts as the lead auditor for routine audits and manages complex audits and inspections; formulates inspection response strategies, coordinates implementation, and assists senior management during high-risk or regulatory-critical inspections.

• Orchestrates activities to ensure inspection readiness.

• Functions as a subject matter expert for one or more elements of the Quality Management System (QMS) such as CAPA, Audit Program, Vendor Quality Management, Inspection Readiness, Training Compliance, and CSV Quality Oversight, while supporting continuous improvement initiatives in these areas.

• Develops, reviews, and maintains controlled documents within the assigned scope and ensures that the assigned processes, procedures, and tools align with the company QMS and relevant GxP regulations.

• Leads and/or conducts quality risk assessments and engages in risk management reviews.

• Reports on Key Quality Indicators (KQIs), Key Performance Indicators (KPIs), quality metrics, trends, and opportunities for improvement.

• Conducts audits, acts as the lead auditor for intricate audits, and supports the planning and execution of the audit program.

• Mentors auditors and promotes audit quality and consistency.

• Oversees vendor qualification and monitoring activities, including risk assessments, Requests for Information (RFIs), performance evaluations, and re-qualification efforts.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or equivalent, or relevant experience in quality management and auditing.

• At least 10 years of proven experience in quality management and quality assurance processes.

• A minimum of 7 years of audit experience across various types of GCP and other GxP audits; experience as a lead auditor is preferred.

• Background in clinical research environments (CRO and/or Sponsor).

• Comprehensive knowledge of GxP regulations and guidance, with the ability to interpret and convert requirements into practical processes.

• Strong grasp of Quality Management Systems, quality standards, inspection requirements, and the management of inspection responses.

• Proficient in MS Office, data analysis tools, and quality assurance software/eQMS tools.

🏝️ Benefits

• We offer a competitive compensation package.

• Comprehensive benefits are included.

• Opportunity for personal and professional growth in a fulfilling environment.