Director, Quality

Precision For Medicine; West Yorkshire; Remote; GBP 70,000 - 100,000; Full time

Job summary

A leading company in the clinical research sector is seeking a Director of Quality to manage audit programs and ensure compliance with regulations. This fully remote position requires a strong background in Quality Assurance, with responsibilities including overseeing compliance activities and mentoring team members. Ideal candidates will have extensive experience in clinical research and a solid understanding of GCP/ICH guidelines.

Qualifications

• 10 years of experience in clinical research with emphasis on Quality Assurance/Compliance.
• CRO, pharmaceutical, and/or medical device experience required.
• Knowledge of GCP/ICH guidelines and FDA regulations.

Responsibilities

• Manage Quality and Compliance functional activities including QMS and SOPs.
• Conduct ICH/GCP quality reviews/audits for clinical trials.
• Support and mentor Quality & Compliance team members.

Skills

Leadership

Interpersonal skills

Problem-solving

Communication

Motivation

Attention to detail

Education

Bachelor’s degree in a science, healthcare, or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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Full Job Description

Precision for Medicine is hiring Director, Quality based in Europe. The position can be covered fully remotely from one of our European locations: UK, Spain, Poland, Slovakia, Hungary, Serbia, or Romania.

Position Summary:

The Director, Quality manages the audit program and supports clinical projects to ensure compliance with regulations and Precision procedures.

Essential functions of the job include but are not limited to:

• Manage Quality and Compliance functional activities, including implementation of the QMS, SOPs, Training, and CAPAs.
• Work closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for the conduct of clinical trials and perform ICH/GCP quality reviews/audits to ensure compliance with applicable regulations.
• Initiate follow-up processes when there is suspicion of scientific misconduct or serious non-compliance.
• Support and mentor Quality & Compliance team members.
• Audit regulatory documents for submission to FDA and global regulatory authorities (e.g., MHRA).
• Provide ICH/GCP guidance, auditing advice, and training to internal and external clients.
• Help counsel on and direct quality initiatives as part of the Management Team, providing ICH/GCP compliance guidance throughout the clinical development lifecycle to enhance and maintain quality cross-functionally.
• Support and enhance the company's Corporate Compliance functions and facilitate business development and proposals, including bid defense and project kick-off meetings.
• Lead audits of systems, sites, documentation, and Trial Master Files to ensure compliance with internal SOPs, project plans, and industry standards.
• Review and audit documents intended for submission to the FDA to ensure regulatory compliance.
• Build upon the current QMS by establishing additional standards and metrics to ensure high-quality services.
• Participate in leading, maintaining, and executing corporate quality initiatives.
• Maintain current knowledge of regulations and guidance documents, providing expert analysis to project teams.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in a science, healthcare, or related field, or equivalent.
• Requires 10 years of experience in clinical research with emphasis on Quality Assurance/Compliance or relevant experience.
• CRO, pharmaceutical, and/or medical device experience.
• Knowledge of GCP/ICH guidelines and FDA regulations.
• Availability to travel up to 30% domestically and internationally.

Skills:

• Strong leadership, interpersonal, and problem-solving skills; excellent communication skills.
• Mastery of GCP/ICH guidelines, FDA regulations, and SOPs. Ability to motivate project teams.
• Ability to review and evaluate clinical data; proficiency in Microsoft Word, Excel, PowerPoint, and some knowledge of Access or similar databases.
• Understanding of financial management for proposals and budgets.
• Self-motivated, able to work independently and in teams.
• Customer service orientation, collaboration, flexibility, and attention to detail.
• Ability to work with cross-functional groups and manage multiple assignments.
• Fluent in English with excellent verbal and written communication skills.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.

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