Senior Quality Assurance & Regulatory Affairs Analyst

About the role

Thermo Fisher Scientific is seeking a Senior Quality Assurance & Regulatory Affairs Analyst to support global healthcare and scientific advancement. You will ensure compliance with GMP, FDA, and international quality standards while working across multiple product lines.

Key responsibilities

• Maintain compliance with cGMP, FDA, and international regulatory requirements.
• Oversee product manufacturing, control, and release processes.
• Lead deviation investigations, CAPA, change control, and root‑cause analysis.
• Perform GxP equipment validation and qualification.
• Support internal audits and external regulatory inspections.
• Manage documentation in quality systems such as TrackWise or MasterControl.

Required profile

• Bachelor’s degree in Pharmacy with eligibility for Technical Direction.
• At least 2 years of experience in pharmaceutical/biotech manufacturing or quality assurance.
• Strong analytical and problem‑solving abilities.
• Excellent verbal and written communication in English.
• Ability to work independently and within cross‑functional teams.

Required skills

• cGMP regulations
• ISO 9001 and ISO 13485 standards
• TrackWise or MasterControl quality management systems
• Deviation investigations, CAPA, change control, root‑cause analysis
• GxP equipment validation & qualification
• Microsoft Office suite
• Technical writing and documentation