Job Description

Job Title:

QA Manager

Location:

Innovation Centre, Ebbw Vale, Wales NP23 8XA

Employment Type:

Full-Time (with some flexibility in working hours)

Department:

Quality Assurance

Reports to:

QA/RA Lead

About Onya Therapeutics

At Onya Therapeutics, we are pioneering novel therapeutics to transform wound care and tissue regeneration. As we prepare for the next phase of our development, we are seeking a full-time QA Manager to help establish and maintain a strong quality framework across our product and operational activities. This is an opportunity to shape quality systems from day one in a high-growth environment focused on patient impact and scientific integrity.

Position Summary

We're looking for a QA professional to lead quality assurance activities that support our quality needs as Onya grows from a pre-clinical to a clinical stage company, with regulatory approved products. You will work closely with all teams involved in the research, development and contract manufacture of topically applied medicinal patches. The ideal candidate will have experience building and managing quality systems in line with GMP and GCP standards, particularly in early-stage biotech or pharmaceutical environments. You will play a critical role in ensuring readiness for future regulatory milestones and product scaling.

Key Responsibilities

Develop, implement, and manage a fit-for-purpose Quality Management System (QMS) preferably eQMS, aligned with GMP/GCP standards Support the Technical Team in establishing suitable QC criteria and analytical methods, overseeing method validation and technical transfer Lead internal audits, manage CAPAs, and ensure continuous improvement across quality processes Support qualification of vendors, including CROs and CDMOs, and maintain audit readiness Establish SOPs and training frameworks for quality-sensitive operations Oversee documentation, record-keeping, and quality metrics reporting Support Quality/RA lead in regulatory discussions and compliance planning Risk Management for R&D Managing the ongoing ISO 13485 certification of Onya Therapeutics Workplace training of employees in conjunction with HR Support H&S management within the business

Candidate Profile

Minimum Requirements:

5+ years of QA experience in the pharmaceutical, biotech, or life sciences sector In-depth understanding of GxP standards (particularly GMP and GCP) Strong documentation and communication skills Ability to implement and maintain quality systems in a resource-conscious setting
Preferred:

Prior experience in early-stage or scaling biotech companies Familiarity with applicable ISO standards (e.g. ISO 13485), MHRA / FDA expectations, and regulatory audits Experience working cross-functionally with R&D, clinical, and manufacturing teams Experience in ISO 14971, ICH Q9 quality risk management Experience in H&S, COSHH, R&D lab assessments

What We Offer

Full-time with some flexibility in working hours A leadership role in building a robust, inspection-ready quality culture from the ground up A collaborative, science-driven team with real potential for impact Competitive compensation reflective of seniority and contribution
Job Type: Full-time

Pay: 27,316.03-63,538.45 per year

Benefits:

Company pension Life insurance * On-site gym