About the role

AI summarised

The Senior QMS Specialist role at Thermo Fisher Scientific focuses on ensuring quality excellence and regulatory compliance across manufacturing operations. The position involves maintaining robust quality management systems, leading investigations, driving continuous improvement, and ensuring GMP/ISO compliance. The role requires collaboration with internal teams and external regulators to resolve quality issues, manage CAPAs, support audits, and implement quality initiatives.

Life SciencesOnsite

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
Maintain robust quality management systems
Work with multiple teams to resolve quality issues
Establish and maintain quality standards

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
Expertise in quality systems including: Change control
Expertise in quality systems including: Risk management and FMEA
Expertise in quality systems including: Document control
Expertise in quality systems including: 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