About Us
We are a team of passionate individuals, developing ground-breaking biological technologies designed to sustainably, and safely, control insects that transmit diseases and destroy crops. We do this work to improve lives and livelihoods around the world in the face of the growing threats that insects pose to human health and the global food supply.
Whilst what we do relates to developing insect control technologies, Oxitec is about people and is in service to people.
We are strongly committed to a set of values, principles, and behaviours, and foster a culture of trust, respect, creativity, and accountability. Click here to learn more, and here to read our CEO's blog about trust and our culture.
Purpose of the Job
Under the guidance of the Head of Global Quality , the QA Manager will lead the development and creation of a global QA team. With technical support from a QA Scientist in the UK you will ensure appropriate local QA support to our production facilities in Brazil. You will be responsible for assessing, shaping and maintaining the Quality Management System (QMS) globally as well as monitoring and managing all non-conformances in the UK.
As the QA Manager within Oxitec you will be responsible for promoting a good quality and continuous improvement culture, you will be an active part of the Quality team, working with all departments to ensure compliance across the UK and other sites.
You will have a can-do mindset and a strong affinity for hands-on activities, show commitment to performance excellence, integrity, and Oxitec's values and principles.
Responsibilities
Manage a small team of Quality Assurance Specialists based around the globe,
overseeing recruitment, training, and performance management to ensure that the team is adequately staffed with qualified professionals.
Maintain the QMS to ISO9001 guidelines.
Maintain and enhance Quality Systems and procedures, including Change Control, Deviations, Complaints, Product Quality Reviews (PQRs), and non-conformances.
Manage risk assessment and documentation, supporting technical knowledge-sharing within the organisation.
Implement and monitor Corrective and Preventative Actions (CAPAs), tracking effectiveness, and preparing reports for senior leadership.
Prepare for and host external regulatory audits.
Lead internal audits, provide reports and review CAPA plans.
Full management of the eQMS, including system administration, ensuring document control compliance, and staff training.
Engage in continuous improvement initiatives to drive operational excellence.
Work with the wider Quality team to ensure compliance with all procedures throughout sites.
Maintain vendor quality qualifications and track vendor complaints. Write / review equipment, process and computer system validations.
Support the Head of Global Quality with any other relevant activities.
Skills, Experience, and Education Requirements
Bachelor of Science or higher degree in a biological sciences or a professionally recognised Quality Assurance qualification (Essential).
Significant experience in Quality Assurance in a similar industry such as life sciences . (Essential).
Experience leading a QA function.
Experience of managing an electronic Quality Management System (Essential)
Qualified Lead Auditor in ISO9001 registered with IRCA with experience of managing internal and external audits to this standard (Essential)
Excellent understanding of ISO 9001, data integrity, GLP, and GMP requirements. (Essential).
Strong attention to detail with excellent written skills, including the ability to write and review accurate non-conformances, change controls, corrective/preventative action plans etc. (Essential).
Ability to train other staff members in Quality related processes. (Essential).
Experienced in vendor management . (Essential).
Experience in preparing companies for ISO 9001 accreditation (Desirable).
Good negotiating skills (Desirable).
Behavioural Requirements
Committed to and passionate about the Oxitec mission and values.
Responsive to the needs of an international business working across different time zones, adapting working patterns in-line with business requirements.
Positive, humble, co-operative and professional always.
Work with a sense of urgency and solve things promptly.
* Resilient and persistent in an innovative and constantly changing environment.
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