Are you a Quality Assurance professional working in drug development? Would you be interested in a fast-paced and wide-ranging role with opportunities for progression?
BerGenBio is a clinical-stage biopharmaceutical company focused on developing innovative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers.
We are looking to recruit a Quality Assurance Manager to work in our Oxford office to provide operational support to the Quality team primarily with GCP activities. We offer hybrid working for all employees therefore this role is based 2-3 days a week in our Oxford office.
Key responsibilities include:
- Development, improvement, and maintenance of our Quality Management System (QMS) including periodic review & revision of SOP’s, ensuring training compliance, managing GxP change control procedures, deviations & investigations, and conducting internal audits and trend analysis and admin support.
- Participating & supporting inspections to ensure inspection readiness.
- Collating KPIs and matrices and addressing any shortfalls.
- Support vendor selection and supplier qualification
- Oversee GxP activities for vendors/suppliers including audit schedule implementation, oversight of vendor deviations, non-conformances, complaints & investigations, and verification of implementation & effectiveness of CAPA plans & deviations.
Knowledge & skills required:
- Bachelor’s degree in a life science subject.
- Experience managing GCP compliance activities
- Understanding and experience of International ICH-GCP and clinical quality laws, regulations and guidelines.
- Experience providing internal consultation and training on quality systems and GCP.
- Previous exposure to GMP would be an advantage
- Experience of regulatory inspections and GCP auditing beneficial
The ideal candidate will be a motivated and proactive QA senior associate with experience managing day to day activities in a QMS, looking to step into a Quality manager role.
As part of a small, dynamic team, the successful candidate will be a self-starter with a willingness to learn. With experience of working collaboratively with other functions of the business, you should be a team player, have strong communication skills and excellent attention to detail.
We have a strong and inclusive company culture and offer a competitive salary, annual discretionary bonus, stock options to all employees, 25 days holiday, up to 10% pension contribution, life assurance, income protection, flexible working hours as standard and opportunities for development.
We are an equal opportunities employer and ensure that all applications are treated appropriately and fairly and that, all things being equal, no candidate is rejected because of their age, gender, race, sexuality or any other protected characteristic.
For full details, please refer to the job description via the button below. To apply please send your CV and a covering letter, including your current salary and package details, to firstname.lastname@example.org.