Qualified Person

OBN (UK) Ltd; Oxford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A life sciences company in Oxford seeks a qualified professional to ensure compliance and certification of Investigative Medicinal Products (IMPs). This role involves leading quality assurance strategies and hosting regulatory audits. Ideal candidates will have a degree in Life Sciences, extensive GMP knowledge, and proven experience in biologics and sterile manufacturing. This position offers competitive rewards and a collaborative working environment.

Benefits

Highly competitive total reward packages

Wellbeing programmes

Development opportunities

Diverse and inclusive working environment

Qualifications

• A Degree or higher level in Life Sciences or related discipline.
• Extensive knowledge of GMP guidelines and regulatory requirements.
• Proven experience in biologics and sterile manufacturing.
• Strong understanding of clinical trial requirements.
• Familiarity with contract manufacturing models.

Responsibilities

• Certifying Investigative Medicinal Products (IMPs) in accordance with GMP.
• Participating in the QA Leadership Team to influence quality strategy.
• Serving as EU Qualified Person (QP) for batch certifications.
• Hosting regulatory inspections and ensuring QMS compliance.
• Overseeing review and approval processes for documentation.

Skills

GMP guidelines knowledge

Biologics and sterile manufacturing

EU and UK regulations understanding

Stakeholder management

Education

Degree in Life Sciences or related discipline

Job description

Key Duties And Responsibilities

• Certifying Investigative Medicinal Products (IMPs) and/or commercial APIs in accordance with GMP and relevant regulations.
• Participating in the QA Leadership / Steering Team to input on quality strategy, objectives, and policies.
• Serving as EU Qualified Person (QP) for batch certifications in line with 2001/83/EC, Regulation 536/2014, and SI2012-1916.
• Hosting and supporting regulatory inspections, audits, and client/partner visits, ensuring QMS compliance and operational excellence.
• Overseeing review and approval processes for records, deviations, environmental monitoring, OOS/OOT results, and related documentation.

Role Requirements

• A Degree or higher level in Life Sciences or related discipline (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
• Extensive knowledge of GMP guidelines, Annex 1 EudraLex Volume 4, and regulatory requirements for IMP and commercial API manufacture.
• Proven experience in biologics, sterile manufacturing, and QMS oversight, including audits and regulatory inspections.
• Strong understanding of EU and UK regulations, clinical trial requirements, and validation systems.
• Familiarity with contract manufacturing models, stakeholder management, and external partner collaboration.

What’s in it for you?

• Highly competitive total reward packages
• Wellbeing programmes
• Development opportunities
• A diverse and inclusive working environment
• Supportive colleagues and collaborative culture
• State‑of‑the‑art laboratory and manufacturing facilities
• Key leadership role within the senior site team

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.