Quality Management Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Quality Management Specialist – Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As an Quality Management Specialist, you will support for operational teams within an assigned country. Performs compliance checks, supports basic quality investigations, reviews documentation for accuracy, and supports audit and inspection readiness. Applies established procedures, receives close guidance on new tasks, and contributes to operational compliance, data integrity and inspection readiness.

What You'll Do:

Perform compliance checks and documentation reviews in accordance with SOPs and QMS requirements.

Support basic quality investigations by gathering information and completing document checks.

Identify and escalate quality issues (QIs) as required.

Support maintenance of accurate file and documentation systems (e.g., ISF, trackers).

Assist in audit/inspection readiness activities (file prep, documentation review).

Provide routine guidance to site staff on SOP adherence and documentation expectations.

Support training activities by preparing materials or reinforcing key points.

Collaborate with operational teams and QAC on routine quality matters.

Contribute to maintaining compliance, data integrity and inspection readiness.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

• Previous clinical research experience is preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Basic understanding of GCP, ICH, SOPs
• Strong attention to detail
• Ability to follow defined procedures
• Basic investigation support skills
• Good organisational/time-management skills
• Effective communication skills
• Proficiency with documentation systems & MS Office

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Indoor environment
• Extended periods of computer work
• High-paced or high-pressure environment

Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.