Sr QA IT/CSV Compliance Specialist

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description:
Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As a Senior Quality Specialist, you'll be responsible for ensuring GxP equipment and computerized system compliance for Fisher Clinical Services Switzerland (Basel) and Germany (Rheinfelden and Weil am Rhein) sites. The role provides Quality Assurance leadership for Computer System Validation (CSV), Data Integrity, and IT compliance activities while ensuring alignment with global GMP requirements. The successful candidate partners with cross-functional teams to drive quality excellence, oversee validation lifecycle activities, support inspections and audits, and maintain robust quality systems that enable Thermo Fisher Scientific's mission.

Responsibilities:

• Serve as the Quality Assurance subject matter expert for IT systems, computerized systems, equipment qualification, and Computer System Validation (CSV).
• Review and approve validation lifecycle documentation including URS, risk assessments, FAT, SAT, IQ, OQ, PQ, validation plans, protocols, reports, and periodic reviews.
• Provide oversight of qualification and validation activities to ensure systems remain in a validated state throughout their lifecycle.
• Lead or support investigations, root cause analyses, CAPAs, change controls, and risk assessments related to computerized systems and equipment.
• Ensure compliance with Data Integrity principles, global GMP requirements, FDA/EMA regulations, 21 CFR Parts 210/211, applicable GAMP and ICH guidance.
• Review and approve SOPs, deviations, validation templates, and quality documentation supporting GxP systems.
• Track periodic reviews and audit trail reviews for computerized systems.
• Represent Quality during customer audits, regulatory inspections, and internal audits; support inspection readiness and responses.
• Collaborate with Engineering, Manufacturing, Validation, IT, and Operations to drive continuous improvement and compliance initiatives.
• Provide technical guidance and mentoring on validation, quality systems, and regulatory expectations.

Qualifications:

• Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Degree in Chemistry, Biology, Microbiology, Engineering, Computer Science, or another relevant scientific or technical discipline.
• Demonstrated experience in Computer System Validation (CSV), equipment qualification, and quality oversight of GxP computerized systems.
• Strong knowledge of FDA, EMA, global GMP regulations, 21 CFR Parts 210/211, Data Integrity, and ICH/GAMP guidance.
• Hands-on experience with investigations, CAPAs, change control, document management, and quality risk management methodologies.
• Experience supporting regulatory inspections, customer audits, and internal audit programs.
• Knowledge of computerized system periodic reviews, audit trail reviews, and computer system lifecycle management.
• Excellent technical writing, communication, analytical, project management, and problem-solving skills.
• Ability to work independently while collaborating effectively across diverse cross-functional teams.
• Computer System Validation expertise, German language skills, and Computer System Validation/Data Integrity specialization are considered advantageous.
• Fluency in English is required.