Qualified Person (QP) (Biotech)

Location: Milton Park, United Kingdom; hybrid with a minimum three-day on-site expectation

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies designed to activate systemic anti-tumor immune responses.

What you will do

• Certify finished product batches for release or export in the EU and UK in accordance with GMP and applicable marketing or clinical trial authorisations.
• Review batch records, QC data, manufacturing conditions, cleaning records, stability data, shipping information, audits, and supply-chain documentation before certification.
• Oversee batch review and execute batch disposition for clinical and commercial products.
• Confirm that manufacturing, testing, sites, materials, personnel, validation, technical agreements, and distribution arrangements comply with applicable requirements.
• Lead the assessment of quality defects, deviations, change controls, complaints, product labels, investigations, and recalls.
• Support continual improvement of pharmaceutical quality systems and GMP compliance.

Requirements

• Eligibility as a Qualified Person under Article 49 of Directive 2001/83/EC.
• At least two years of relevant pharmaceutical industry experience.
• Knowledge of EU and UK GMP regulations and guidelines.
• Experience with sterile products; experience with Advanced Therapy Medicinal Products is preferred.
• Relevant bachelor's or master's degree, Ph.D., or other postgraduate scientific qualification.
• Commitment to maintaining current regulatory and industry knowledge through continuous professional development.

Culture & Benefits

• Work focused on developing therapies for cancer treatment and improving patient outcomes.
• Collaborative, bold, dedicated, and candid working principles.
• Opportunity to contribute to clinical and commercial product quality across EU and UK operations.