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Senior Scientist Quality Assurance Qualification - Job Opportunity at Thermo Fisher Scientific

Lengnau, Switzerland
Full-time
Senior
Posted: May 11, 2025
On-site
CHF 120,000 - 160,000 per year based on Swiss market conditions and senior level responsibility

Benefits

Comprehensive professional development program with task-specific training
Dynamic international work environment
Cultural diversity and inclusion initiatives
Career growth opportunities within a global leader

Key Responsibilities

Lead GMP compliance oversight for qualification activities across facilities, utilities and equipment with organization-wide impact
Drive strategic quality assurance initiatives through cross-functional collaboration with Manufacturing, QC, and Engineering teams
Provide senior-level guidance on qualification standards and compliance requirements
Spearhead continuous improvement of quality systems and manufacturing processes
Direct quality documentation review and approval processes
Lead internal/external inspection preparation and remediation efforts

Requirements

Education

Bachelor's or Master's degree in Engineering or Life Sciences (Biology, Chemistry, etc.), or equivalent

Experience

min 5 years Experience in Pharma manufacturing site

Required Skills

Proficiency in working with multicultural and cross-disciplinary project teams Excellent organization, planning, problem solving and critical thinking skills Excellent writing, communication, and presentation skills Language: Proficiency in English, German knowledge preferable
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Sauge AI Market Intelligence

Industry Trends

The biologics manufacturing sector is experiencing rapid growth, driven by increasing demand for complex biological therapeutics and personalized medicine solutions Quality Assurance roles are becoming increasingly strategic as regulatory scrutiny intensifies and manufacturing processes become more sophisticated The shift toward single-use technologies and flexible manufacturing platforms is creating new qualification challenges and opportunities

Role Significance

Typically leads or coordinates with a team of 5-8 QA professionals while interfacing with multiple departments
Senior strategic position with significant influence on quality systems and regulatory compliance

Key Projects

Implementation of qualification protocols for new biological manufacturing processes Development and optimization of quality systems for complex biologics production Management of regulatory inspection preparation and response Cross-functional quality improvement initiatives

Success Factors

Deep understanding of GMP requirements and their practical application in biologics manufacturing Ability to navigate complex stakeholder relationships across multiple departments Strong technical expertise combined with excellent communication skills Strategic thinking with practical problem-solving capabilities

Market Demand

High demand with growing emphasis on biologics expertise and qualification experience in modern manufacturing environments

Important Skills

Critical Skills

GMP compliance expertise for complex biological manufacturing processes Cross-functional leadership and stakeholder management Technical documentation and qualification protocol development Risk assessment and mitigation in qualification activities

Beneficial Skills

Experience with single-use manufacturing technologies Knowledge of Swiss and EU regulatory requirements Project management certification Understanding of lean manufacturing principles

Unique Aspects

Opportunity to work with cutting-edge biologics manufacturing technologies
Combination of traditional stainless steel and modern single-use equipment expertise required
High-growth facility with significant expansion plans
Position involves shaping quality systems for future manufacturing capabilities

Career Growth

Typical progression to director level within 3-5 years given strong performance and business growth

Potential Next Roles

Quality Assurance Director Site Quality Head Global Quality Systems Leader Technical Operations Director

Company Overview

Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in serving science with approximately $40 billion in annual revenue and over 100,000 employees worldwide

Industry leader in scientific research and innovation with strong presence in biologics manufacturing and pharmaceutical services
Strategic location in Switzerland's biotech corridor with significant investment in state-of-the-art facilities
Innovation-driven environment with emphasis on scientific excellence and professional development
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