This is a permanent position, paying around £55,000 plus 10% bonus, stock options and excellent benefits. The salary may be slightly negotiable depending on experience. You will be based in the company’s modern site in London, though they have a very healthy approach towards the current Covid-19 guidelines and can discuss you working some portion of the time from home, not just in the short term.
Reporting to the Head of QA, your role will include:
- Performing routine QA duties to ensure compliance to GCLP and other regulatory requirements relating to oversight of clinical laboratory activities for cellular therapies.
- Review and approval of documentation including SOPs, policies and forms, ensuring compliant templates, considering usability, accuracy, consistency and quality.
- QA support for GCLP associated Quality System Documents such as Change Controls, Deviations, Root Cause Investigations and Corrective and Preventative Actions (CAPAs).
- Verifying completion of actions from Quality System Documents such as Change Controls, Deviations, Investigations, CAPAs, Audits and update relevant Quality Logs.
- QA support for GCLP assay activities (qualification & validation) according to regulatory guidelines.
- QA support for laboratory set up and transfer including equipment qualification activities.
- Implementing or improving processes used in the GCLP laboratories.
- QA review of GCLP laboratory worksheets and reports.
- Performing internal and external audits relating to GCLP activities.
- Supporting vendor qualification of third parties contributing to the overall GCLP, process development and translational science activities including external audits as necessary.
- Coordinating and delivering GCLP Training to key stakeholders in accordance with training plans.
- Provision of associated in-house QA training activities
- Provide support and data for Quality Management reviews.
- Inputting into company policies and governance as the company grows.
- Support to cross functional teams, predominantly the Translational Science team, in the oversight and execution of global operation systems, in collaboration with GCP and GMP quality personnel.
- Working collaboratively with GCP and GMP Quality personnel to build a fully integrated QMS.
- Assisting with GCLP regulatory inspection preparation activities and follow-up activities.
Benefits:
In addition to a generous basic salary (£50k - £55k, with potential negotiation), the company offers 10% annual bonus, stock options and excellent benefits.
Skills and Experience Required:
- Scientific education (MSc, BSc or equivalent) in Biochemistry, Biology, Biomedical Science, Pharmacy or similar
- Strong experience of Quality Assurance gained within a regulated GLP / GCLP environment (knowledge of GxP and HTA would be a strong advantage too)
- Understanding of quality requirements for cell therapy / ATMP products would be a big advantage
- Expertise in lab equipment qualification and assay validation activities, as well as developing and maintaining quality systems / document management systems
- Experience in planning, managing and executing vendor and site
- Strong proficiency in Word, Excel and PowerPoint
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Hammersmith, London, paying around £55,000, though this could be higher depending on experience.