Client: Pharmaceutical Client
Role: Qualified Person (QP) - Head of Quality
Location: London, UK
Required:
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Microbiology, Engineering, or related scientific discipline.
- Minimum 10–15 years of pharmaceutical, biotechnology, or biologics manufacturing experience.
Description:
The Qualified Person (QP) is responsible for ensuring that medicinal products are manufactured, tested, stored, and distributed in compliance with applicable GMP regulations, marketing authorizations, regulatory commitments, and company quality standards. The QP serves as the final quality authority for batch certification and release decisions and provides strategic quality oversight across manufacturing, quality control, validation, engineering, supply chain, and regulatory functions.
The position requires extensive knowledge of pharmaceutical manufacturing processes, quality systems, contamination control strategies, regulatory requirements, and risk management principles. The QP is expected to exercise independent judgment in evaluating product quality, patient safety, and regulatory compliance.
Key responsibilities:
- Perform final review and certification of clinical and commercial drug substance and drug product batches.
- Ensure all manufacturing, packaging, testing, and release activities are conducted in accordance with applicable GMP regulations and approved procedures.
- Review executed batch records, laboratory data, environmental monitoring results, deviations, investigations, CAPAs, change controls, and quality events prior to disposition decisions.
- Evaluate product quality impact and determine batch release, rejection, or additional assessment requirements.
- Maintain oversight of batch disposition activities and product release timelines.
- Provide quality oversight for deviations, CAPAs, change controls, risk assessments, complaints, and supplier quality activities.
- Provide quality oversight for upstream, downstream, fill-finish, packaging, warehousing, and distribution operations.
- Partner with Manufacturing, Quality Control, Validation, Engineering, MSAT, Supply Chain, Regulatory Affairs, and Client Quality teams.
Key requirements:
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Microbiology, Engineering, or related scientific discipline.
- Minimum 10–15 years of pharmaceutical, biotechnology, or biologics manufacturing experience.
- Extensive experience in GMP-regulated environments.
- Experience supporting sterile manufacturing, biologics, cell therapy, gene therapy, or advanced therapy medicinal products preferred.
- Demonstrated experience with product disposition and batch release activities.
- Experience leading complex investigations, CAPAs, and quality system improvements.
- Prior experience supporting regulatory inspections and customer audits.
- EU GMP Annex 16
- FDA cGMP Regulations
- Quality Risk Management (ICH Q9)
- Pharmaceutical Quality Systems (ICH Q10)