We are at the centre of the rapidly growing cell and gene therapy sector. We are proud to deliver life-changing therapies together, and so can you. We are currently recruiting for a Senior Vice President, Head of Global QA. In this role, reporting to the CEO with a doted line to COO, you will play a pivotal role in ensuring the highest standards of quality and compliance across our global operations. Based ideally in either UK or France, you will lead the strategic direction, development, and implementation of our quality assurance policies, systems, and processes to uphold regulatory requirements and exceed customer expectations. Your responsibilities in this role would be: Leadership and Strategy: • Provide strategic leadership and direction for the global QA function, aligning with organisational goals and objectives, in consultation with Corporate Executive Team. • Develop and execute QA strategies to drive continuous improvement, operational excellence, and regulatory compliance, ensuring alignment across global sites. • Foster a culture of quality, integrity, and accountability throughout the organisation, collaborating with site leadership teams. Regulatory Compliance: • Via Regulatory site leads, oversee compliance with international regulatory requirements (e.g., FDA, EMA, MHRA, etc.) and industry standards (e.g., GMP, GLP, GXP). • Oversee timely submission of regulatory filings and support regulatory inspections and audits. Quality Management System: • Establish a robust quality management system (QMS) globally to support product development, manufacturing, and distribution activities. • Through the global QA leadership team, implement and maintain policies, procedures, and guidelines to ensure consistency and standardization across all sites. Quality Oversight: • Implement a reporting process, including metrics / KPI’s for the QA site leads, to enable review of quality activities including: batch release, deviation management, change control, investigations, and CAPA (Corrective and Preventive Actions), as well as, regular reviews and assessments to monitor compliance and identify opportunities for improvement. Supplier and Customer Quality Management: • Collaborate with supply chain and procurement teams to ensure the qualification and management of suppliers and contract service providers. • Partner with customers to address quality-related concerns, ensure customer satisfaction, and maintain strong partnerships. Talent Development: • Recruit, develop, and retain top talent within the QA and regulatory leadership organisation. • Provide mentorship, coaching, and training to build a high-performing and engaged team. We are looking for: • Progressive global experience in quality assurance gained in the pharmaceutical or biotechnology industry, within a leadership role. • Extensive knowledge of global CMC regulatory requirements and quality standards applicable to drug development and manufacturing, leading audits. • Proven track record of successfully leading and managing QA and regulatory teams in a multi-site, global environment. • Spearheads innovative approaches to quality assurance processes and systems, leveraging emerging technologies and best practices to enhance efficiency, effectiveness, and compliance. • Demonstrates exceptional problem-solving skills, adept at identifying root causes of quality issues and implementing targeted solutions to prevent recurrence and drive continuous improvement. • Champions a culture of innovation and problem-solving within the QA organisation, fostering collaboration, creativity, and agility to adapt to evolving regulatory requirements and industry challenges. • Cultivates a culture of trust, accountability, and respect within the QA organisation, promoting open communication, inclusivity, and teamwork to drive collective success and continuous improvement. • Excellent communication, interpersonal, and influencing skills. • Ability to travel domestically and internationally as needed. 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 live 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 30 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. 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 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. 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. 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 30 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. 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 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. 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.