Qualified Person

Work Schedule

Environmental Conditions

Job Description

JOB CODE: .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 2700 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 youll 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.