Quality Assurance Manager

ZipRecruiter; London; On-site; GBP 50,000 - 90,000; Full time

Job summary

Join a pioneering biotechnology firm as a QA Manager in London, where your expertise will be vital in establishing quality standards for clinical candidates. In this impactful role, you will lead the Quality Assurance function, ensuring products meet the highest efficacy, safety, and quality standards. Collaborate with external vendors, coordinate audits, and foster a culture of quality across the organization. This is a unique opportunity to make a significant contribution to the development of groundbreaking therapies in a dynamic and supportive environment.

Qualifications

• Extensive experience in Quality Assurance with a focus on third-party supply chains.
• Knowledge of ATMPs and GMP for large molecular/complex molecules is essential.

Responsibilities

• Establish and maintain the Quality Assurance function and QMS.
• Promote quality mindset and ensure compliance with regulatory standards.

Skills

Quality Assurance

Regulatory Compliance

Vendor Audits

GMP

GCP

Education

Relevant degree in Biological, Pharmaceutical, or related Sciences Discipline

Tools

Quality Management System (QMS)

Job description

Job Description

ROLE OVERVIEW:

We are currently looking for a QA Manager to join a leading biotechnology company based in the London area. As the QA Manager, you will be the first full-time quality appointment to join and support the company as they develop their clinical candidates closer to commercialization. Your core focus will be to take responsibility for ensuring that products are developed in accordance with the highest efficacy, safety, and quality standards.

KEY DUTIES AND RESPONSIBILITIES:

1. Accountable for establishing the Quality Assurance function and maintaining the Quality Management System (QMS) in accordance with global regulatory requirements.
2. Promoting a quality mindset throughout the organisation, providing support and guidance to all functions to ensure compliance with the QMS.
3. Acting as the primary quality contact with external vendors, including manufacturing partners, to ensure the highest quality standards are maintained.
4. Coordinating external vendor audits and ensuring follow-up in addressing associated corrective actions.

ROLE REQUIREMENTS:

1. Relevant degree in Biological, Pharmaceutical, or related Sciences Discipline.
2. Extensive industry experience in a Quality Assurance role with proven experience delivering quality via a third-party supply chain.
3. A working knowledge and practical experience with ATMPs (Advanced Therapy Medicinal Products) is highly desirable; however, GMP with large molecular/complex molecules is required.

Key Words:

QA Manager / Quality Assurance / Biotechnology / London / QMS / Regulatory Compliance / ATMPs / Vendor Audits / GMP / GCP / Pharmaceutical / Cell and Gene Therapy / Gene Therapy

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.