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.
#J-18808-Ljbffr