Job DescriptionAre you a QA professional with a passion for developing and maintaining Quality systems within a Biologics environment? Do you have expertise gained in a GLP / GCLP lab setting, with experience in laboratory equipment qualification and assay validation activities? We are looking for a QA Manager to join a pioneering T-cell therapy company in Hammersmith, London. You will perform and lead GCLP QA activities including laboratory and Quality System documentation review, lab assay validation protocols and reports, equipment qualification protocols etc, alongside continuously improving and maintaining the QMS. This is a newly created permanent role and is a unique chance to join a company that is growing exponentially.
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.
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.