- Experience Level
- Experienced (non-manager)
Be Inspiring and lead a team of Specialists
Oxford BioMedica is a pioneer of gene and cell therapies and our work is helping to deliver life changing treatments.
As a result of our success we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment, IT systems and processes. We therefore are able to offer the opportunity to a talented people manager to help shape our Validation function and its people.
You will be:
- Identifying and maintaining the validation schedule to keep all manufacturing and laboratory facilities, equipment/systems, utilities and processes in a qualified state to support GxP requirements
- Managing a team of permanent and contract Validation Specialists and resources to ensure preparation and execution of validation protocols (equipment, computerised systems and processes) to support on-going business activities
- Responsible for the regulatory compliance of all validation activities
- Representing the business in customer audits and regulatory inspections as a Validation Subject Matter Expert
- Directing, instructing and supervising OEM vendors and validation service providers as required when external support is utilised for qualification activities
- Creating / reviewing / maintaining qualification related records, procedures, documents and drawings
- Ensuring compliance with safety, health and environmental (SHE) legislation
- Engaging with project teams to identify resource requirements to support scheduled activities
You will need:
- Bachelor’s degree in a relevant scientific, engineering or related discipline
- Demonstrated understanding of validation requirements for international markets including (but not limited to) the US FDA and EMA
- Knowledge of regulatory/GMP requirements for the qualification/validation of bulk biologics substance, finished product manufacturing and laboratory operations
- Significant validation experience within a GxP environment; experience of new manufacturing/analytical technologies and capital projects would be an advantage
- Demonstrable experience of managing a Team in a pharmaceutical, medical device, consumer healthcare or related industry
- Proven problem solving skills/diagnosing faults/resolving qualification issues
We look forward to receiving your application
No agencies please.