Title: Senior Strategic QA Manager
Location: UK (remote)
Sector: Oncology
Contract: Permanent on a part-time basis or freelancers considered
SciNova are supporting an international late-stage Oncology scale-up who are searching for a Senior QA Strategic Manager during a critical phase of growth. This role will play a central part in driving GMP readiness and preparing the organisation for global health authority inspections, including FDA and EMA. This is a hands-on and strategic position, working closely with c-suite and senior stakeholders to ensure robust, phase-appropriate Quality systems aligned with EU and US regulatory expectations.
The role is fully remote within the UK and offers flexibility through either a freelance engagement or a permanent part-time contract.
Role responsibilities:
* Provide strategic Quality leadership across late-stage clinical development and transition to commercialisation.
* Lead and deliver GMP readiness activities in preparation for clinical and commercial manufacturing.
* Drive inspection readiness and act as a key QA lead for FDA and EMA inspections.
* Ensure compliance with GLP/GMP/GCP requirements.
* Lead, maintain, and scale the company’s Quality Management System (QMS) to ensure inspection readiness.
* Act as a senior QA partner to Clinical, Regulatory, CMC, Supply Chain, and other critical internal stakeholders.
* Plan and lead internal audits, mock inspections, health authority inspections, and vendor audits.
* Provide mentorship, training and guidance to the existing QA team.
Role requirements:
* MSc or PhD in a relevant scientific discipline is highly preferred.
* Extensive experience in a senior QA position within the Biotech/Biopharma stage leading late stage development (II/III) projects preferably within oncology (other therapeutic areas considered).
* Demonstrated experience delivering GMP and inspection readiness for FDA and EMA.
* Experienced in mentoring, guiding and training internal QA professionals.
* Ability to operate effectively at both strategic and operational levels.
* Excellent communication skills and confidence engaging with senior leadership and external partners
* Fluent English.
* Obtain the right to work in the UK without need for sponsorship.
What my client offers:
* Competitive salary and performance-based bonus.
* A collaborative and innovative work environment.
* Excellent professional development and growth opportunities.
* Fast-paced scale-up culture.
How to apply:
Send your CV to lauren.howes@scinovasearch.com or apply via LinkedIn.