Process Compliance Team Lead

We want you to feel inspired every day. We’re future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you.

We are currently recruiting for a Process Compliance Team Lead to join the Manufacturing team. The purpose of this role is to lead a team of Process Compliance Officers and Senior Process Compliance Officers in managing the Quality Management System (QMS) and self-inspections processes for the manufacturing department as well as ensuring compliance to internal and external GMP standards.

Our manufacturing team is a critical part of OXB’s operations. We produce multiple clinical and commercial lentiviral vector-based gene therapy products.

Your responsibilities in this role would be:

• Taking accountability for the performance of a team of Seniors and Process Compliance officers
• Ensuring compliance with internal and external GMP requirements, resulting in successful regulatory audits, product license applications or renewal of regulatory product license
• Ensuring consistent Process Compliance standards across OXB manufacturing assets
• Ensuring the implementation of Process Improvement initiatives within the Manufacturing Facility, with the intention of reducing/eliminating deviation (non-compliance) events
• Facilitating the implementation and maintenance of a comprehensive and standardised training programme for the Manufacturing department (in relation to compliance)
• Acting as the Subject Matter Expert (SME) for the QMS process within the Manufacturing department. This includes DEV, DI, CAPA, CC’s and EME’s/EMEI’s
• Delivering key metrics and trends to stakeholders across the company to reflect the current status of the QMS for Manufacturing

We are looking for:

• Graduate in a science-based subject, and/or experience of working to GMP standard within an aseptic manufacturing environment
• Knowledge of GMP production and documentation requirements
• Managerial experience is desirable
• Knowledge of local and international GMP standards and a working knowledge of pharmaceutical quality management systems, including a broad, cross-functional knowledge of how a pharmaceutical business functions on a day-to-day basis.

About Us:

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

What’s in it for you:

• Highly competitive total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Responsible, Responsive, Resilient, Respect
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives