Quality Assurance Officer I (Biotech)

Location: Milton Park, United Kingdom; 5-day on-site expectation

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies designed to activate durable systemic anti-tumor responses and transform cancer treatment.

What you will do

• Provide guidance and coordination for the development, implementation, and maintenance of quality assurance systems.
• Perform GMP batch reviews and support Qualified Person release of drug products for clinical and commercial use.
• Drive improvements across change control, deviation, CAPA, root-cause investigation, and GMP compliance systems.
• Review and approve SOPs, validation protocols and reports, GMP records, testing records, and other controlled documents.
• Lead or participate in risk assessments, audits, compliance walkarounds, training, and inspection-readiness activities.
• Work cross-functionally with Quality Assurance, Quality Control, Regulatory, Clinical, Product Development, and external suppliers.

Requirements

• Bachelor’s degree or equivalent in a relevant discipline; a master’s degree is preferred.
• At least 4 years of relevant experience in quality systems, technology, or supervision within a regulated biotechnology or pharmaceutical environment.
• GxP experience, including auditing, and knowledge of MHRA and EMA GMP requirements.
• Strong written and verbal communication skills, attention to detail, and time-management abilities.
• Competence with Microsoft Office and the flexibility to manage varying workloads.
• Ability to work on-site at the Milton Park location five days per week.

Culture & Benefits

• Collaborative, bold, dedicated, and candid working principles.
• Opportunity to contribute to therapies intended to transform cancer care.
• Competitive and forward-looking total rewards program.
• Work across clinical, commercial, quality, regulatory, and manufacturing operations.