Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

As Quality System Manager, you will lead a dedicated team in maintaining excellent quality in all operations. You will ensure compliance with cGMP and regulatory standards while promoting continuous improvement.

Responsibilities

Ensure the safety message is actively implemented and lived throughout the organization.Hire, develop, and lead professionals within the QMS group, carrying out performance management.Collaborate with the Quality Director and Site Leadership Team to improve the Quality Culture within the organization.Forecast, track, and present the budget for QMS, aligning with PPI and initiating cost control measures.Lead internal audits, regulatory inspections, and customer audits.Author and review deviation investigations, ensuring timely closures and proactive system trending.Drive performance metrics and quality commitments within the quality system.Facilitate "Quality on the Floor," promoting quality culture and 4i values through coaching and mentoring.Ensure GMP documentation is completed to required standards and timescales.Prepare procedures, technical documents, and lead investigations, reviews, and approvals.Proficiently use electronic documentation systems like TrackWise and EDMS.Ensure new products, equipment, and processes meet internal and external standards.Lead effective self-inspection, supplier qualification, and audit processes.Implement data integrity principles throughout the product lifecycle.

EHS

Ensure implementation of emergency procedures and safe work systems.Align with environmental, health, and safety rules and instructions.Report and investigate all accidents, near misses, and rule violations promptly.

Minimum Requirements/Qualifications/Skills

Minimum a Degree in Chemistry, Pharmacy, or Microbiology or equivalent experience.Exposure for the FDA and EU GMPConfirmed experience of at least 10 years in a pharmaceutical Quality department.Deep understanding of cGMP regulations and international guidelines.5-10 years of Quality Assurance experience in a sterile manufacturing facility.Sound GMP compliance decisions and lead QMS.Proactive understanding of GMP principles and relevant regulations.Strong leadership, communication, and problem-solving skills.Excellent written and verbal communication.Ability to work in a fast-paced, matrix environment.Experience with Health Agency/internal audits and the flexibility to prioritize multiple tasks.

At Thermo Fisher Scientific, each one of our 75,000 outstanding minds have a unique story to tell. Join us and supply to our singular mission.