Description

Manage quality systems and ensure site-level compliance within a GMP environment.

This role is on-site.

Responsibilities

• Review systems and analyze paper or electronic data to resolve data integrity and consistency issues.
• Support site inspection preparation, management, and response processes.
• Conduct periodic compliance audits of the Quality Management System (QMS) and support quality management reviews.
• Represent Quality Assurance on project teams and integrate risk management concepts into the quality system.
• Monitor key performance indicators and escalate high-quality risks according to established procedures.

Required Skills

• Minimum 3 years of experience in biopharmaceutical-based GMP manufacturing operations.
• Previous Quality Assurance experience with Data Integrity (ALCOA+) compliance.
• Experience supporting cGMP manufacturing through QMS administration and enforcement.
• Direct experience reviewing and authoring standard operating procedures.
• Practical experience in quality risk management and applying risk-based approaches.
• Technical writing experience and excellent oral and written communication skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Working knowledge of cGMP, ICH, FDA, and EU regulations and guidelines.

Preferred Skills

• Experience as an internal auditor.
• Experience with US and international regulatory agency inspections.
• Experience with viral gene therapies or orphan disease indications.

Key Skills

Education

Any Graduate