Senior Strategic QA Manager
Posted Today by SciNova
Negotiable
Undetermined
Remote
United Kingdom
Summary: The Senior Strategic QA Manager role at SciNova involves leading quality assurance efforts during a critical growth phase for an international late-stage Oncology scale-up. This position requires strategic oversight of GMP readiness and compliance with global health authority inspections, including FDA and EMA. The role is fully remote within the UK and offers flexibility for either a permanent part-time contract or freelance engagement. The successful candidate will work closely with senior stakeholders to ensure robust quality systems aligned with regulatory expectations.
Key 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.
Key Skills:
- 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.
- 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.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.