Qualified Person

Work Schedule

Environmental Conditions

Job Description

JOB CODE: QUA.QAPN.M07

JOB PROFILE: Clinical Qualified Person, Manager

BAND: 7

Location: Ireland only

Type: Remote

Summarized Purpose:

Join Us as Manager Qualified Person – Make an Impact at the Forefront of Innovation

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 a Manager Qualified Person, you will be responsible for defining, managing and improving the quality management system, ensuring internal and/or client processes, systems and/or projects are compliant with requirements and investigational medicinal products, placebos, and/or comparators are QP certified in compliance with GMP and Regulatory filings.  Ensure delivery of quality solutions in a collaborative cross-functional environment. Lead process improvement initiatives and communicates with internal operations regarding continuous improvements.

What you’ll do:

•Certifies batches prior to release ensuring that specific and detailed requirements and regulations have been met including the principles and guidelines are followed.

• Maintains up-to-date knowledge and experience in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.

• Ensures that Quality Assurance Agreements are set up with the Trial Sponsor.

• Performs GMP facility audits involved in the manufacturing of investigational medicinal products used in the clinical study.

• Communicates with Project Management, Clinical Supply, Regulatory and Clinical functions internally as well as with the Trial Sponsor.

• Sets up and maintains Product Specification Files (PSF) for the medicinal products to be released for a clinical study as well as a register or all released batches.

• Develops and improves procedures related to the QP release process.

• Leads quality and compliance processes and engages cross-departmental staff to ensure appropriate execution and completion.

• Develops guidance and reference information, repositories and communication channels including policies, procedures, guidance documents, or quality management systems training.

• Leads and/or participates in process/quality improvement initiatives.

• Develops tools and other materials for tracking of compliance management activities.

• Creates formal networks with key contacts across the department.

• Participates in the resolution of issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.

Requirements:

• Eligible to act as Qualified Person
• Extensive demonstrated pharmaceutical quality experience
• Must have thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing and distribution processes and associated GMP/GDP requirements
• Audit experience would be desirable
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Knowledge of appropriate regional regulations and applicable global pharmaceutical industry regulations and guidelines
• Detail oriented with ability to deal with multiple and changing priorities

Work 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:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.
• Personal protective equipment required such as protective eyewear, garments and gloves

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.