Clinical QA Manager
Location: White City, London
At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £59M with a further £2M contributed by UCL Technology Fund.
Clinical QA Manager
Quell is seeking a candidate with strong GCP and some GCLP/GLP knowledge with experience in the field of Cell and Gene therapies to provide day to day Quality and Compliance support to clinical trials being conducted by Quell Therapeutics Ltd as well as support for Quell laboratories performing exploratory analysis of clinical trial patient samples.
The Clinical QA Manager will help establish and manage our Quality System as it relates to GCP including writing, reviewing, approving and/or maintaining Standard Operating Procedures and other clinical documentation. They will work closely with the Clinical team to provide oversight of external vendors and to address any quality related issues.
The Clinical QA Manager will provide support to internal laboratories undertaking analysis of clinical trial sample to help establish best practice and ensure integrity of data.
The Clinical QA Manager will take day to day responsibility for ensuring company systems and procedures, including those covering clinical trial and laboratory activities, are phase appropriate, fit for purpose, consistent and meet external and internal requirements.
Reporting to the Senior Director of Quality but working as part of the Clinical Team this role will coordinate the implementation of the company quality management system relevant to GCP including external vendor oversight, training on quality procedures and monitor performance against agreed standards.
- Serves as Clinical Quality lead for clinical trial programs.
- Ensures compliance of clinical studies with internal SOPs and clinical plans as well as with applicable worldwide regulations and guidelines to ensure adherence to GCP in conduct of clinical trials and the quality and integrity of generated data.
- Evaluates, writes and/or reviews documentation generated by internal or external parties (e.g. SOPs, Essential documents, Clinical Plans)
- Contribute to the with the establishment, development and day to day management of a cross company GxP quality management system including document control, risk management and CAPA management. Ensure clinical quality requirements are fit for purpose and are appropriate to the clinical phase.
- Assists with the selection and leads the qualification process for selected external vendors and with Clinical Operations provides oversight for outsourced contracted clinical activities.
- Establishes audit plans and leads, participates or manages (via consultants) audits (and follow up of action plans) including internal, vendors, clinical sites, external laboratories, suppliers.
- Quality supports for supply chain activities related to the procurement of starting material and delivery of final product.
- Provides support to establish fit for purpose practices that ensure traceability and data integrity for internal laboratories in particular those analysing clinical patient samples
- Provide GCP/GCLP/GLP guidance as appropriate to clinical project teams, including risk identification/mitigation of potential of identified operational issues/deviations.
- Identifies and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote improvements.
- Participate in project meetings (internal and external) as Clinical Quality representative.
- Planning and implementing regular GCP training and other quality related clinical training
- Assists in inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.
- Manages the archiving of GxP documentation and acts as the named Company Archivist
EXPERIENCE WE ARE LOOKING FOR
- Minimum 5 years of experience in pharmaceutical/biotechnology industry in a GCP QA role
- Experience of conducting internal and external audits
- Experience of Vendor oversight especially CRO’s, external contract laboratories
- Experience providing Quality support for Cell or Gene Therapy programmes is highly desirable
- Experience supporting Clinical Quality laboratories would be advantageous
- Formerly acting as named archivist is desirable
TECHNICAL SKILLS REQUIRED
- Bachelor’s Degree in Life Sciences, Pharmacy, Regulatory
- Expert knowledge of pharmaceutical regulations, standards, and current industry regulatory practices related to GCP with an understanding of the considerations for ATMP’s
- Skilled at maintenance and monitoring of a QMS preferably including experience in a small/ start-up organisation environment.
- Experience of eQMS’s would be an advantage
- Understanding of immunology is desirable
- Audit training e,g. Lead auditor course would be beneficial
- Highly organized with thorough attention to detail
- Able to be pragmatic, take a phase appropriate, risk-based approach to find workable solutions and evaluate quality related issues based on risk
- Strong verbal and written communication skills and interpersonal skills.
- Able to build collaborative relationships enabling effective and harmonious interactions with internal stakeholders and external vendors
- Ability to promote the awareness of quality requirements throughout the company
- Ability to effectively coach, mentor and train staff in quality related activities
- Can handle multiple projects and changing priorities
- Holidays: 25 days per year
- Life Assurance: 4 x base salary
- Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
- Private Medical Insurance for your whole family
- Annual Bonus
- Fantastic collaborative environment at Translation & Innovation Hub
- £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
- Flexible working
- Fast paced and progressive company looking for future leaders and innovators