Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 PersonExtensive demonstrated pharmaceutical quality experienceMust have thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing and distribution processes and associated GMP/GDP requirementsAudit experience would be desirableWorks 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 guidelinesDetail 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.