Quality Assurance (QA) Manager

Job description:

We pride ourselves on our integrity. We do what’s right for our employees, patients and partners, and so can you.

We are currently seeking to hire a talented QA Manager to oversee the Quality Assurance teams to ensure on time delivery of batches while ensuring compliance with regulatory requirements and industry standards. This role involves managing QA teams, QA processes, leading audits, and implementing quality improvement initiatives to maintain the highest standards of product quality and safety.

Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP guidelines. The team are accountable for internal and external audits, quality compliance and control.

Your responsibilities in this role would be:

• Lead the QA teams, providing training, mentorship, and performance evaluations
• Effectively deploy QA resources to support GxP operations and ensure timely delivery of quality documents
• Maintain oversight of Client projects from a Quality perspective and ensure quality aspects of the project are met.
• Develop, implement, and maintain QA policies and procedures.
• Ensure compliance with MHRA, FDA, EMA, and other regulatory requirements.
• Lead internal and external audits, including preparation, execution, and follow-up.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Monitor and report on key quality metrics and trends.
• Support the validation of manufacturing processes, equipment, and systems.
• Ensure proper documentation and record-keeping practices.

Profile description:

We are looking for:

• Higher National Certificate or Degree in Science discipline
• Working knowledge of GMP & Quality related pharmaceutical regulations & standards within Biologics Manufacturing
• Awareness and understanding of Validation and Quality Management systems
• Management and leadership experience.
• Experience of conducting quality audits, investigations and root cause analysis
• Experience of regulatory and or customer /client audits and inspections.
• Proven cross departmental collaborator with the ability to influence other key functions such and drive the Quality agenda
• Good interpersonal and communication skills
• Ability to adapt communication to suit the audience

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.

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

We offer:

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.

This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).

Oxford Biomedica'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.