About the role

AI summarised

This Senior QMS Specialist role at Thermo Fisher Scientific involves ensuring quality excellence and regulatory compliance across manufacturing operations in the pharmaceutical, medical device, or biotech industry. The position combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO compliance.

Life SciencesFull-timeGeneral

Key Responsibilities

Ensure quality excellence and regulatory compliance across manufacturing operations
Help ensure products meet the highest standards while supporting the mission to enable customers to make the world healthier, cleaner and safer
Combine technical expertise with quality oversight to maintain robust quality management systems
Lead investigations
Drive continuous improvement
Ensure GMP/ISO compliance
Work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support audits, and implement quality initiatives
Help establish and maintain quality standards while supporting a culture of continuous improvement and compliance

Requirements

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)
Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
ASQ certifications (CQE, CQA) desired
Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
Expertise in quality systems including CAPA and deviation management, change control, risk management and FMEA, document control, internal/external auditing
Advanced problem-solving and root cause analysis skills
Excellent project management abilities
Strong verbal and written communication skills
Proficiency with quality management software and MS Office
Experience with validation and qualification protocols
Knowledge of statistical analysis and quality tools
Ability to work both independently and collaboratively
Strong attention to detail while maintaining broad perspective
Excellent interpersonal skills for cross-functional collaboration
May require up to 15% travel
Additional language skills may be beneficial