Quality Assurance Project Manager
Good Clinical Practice (with GMP awareness)
Ellipses is a global clinical-stage drug development company focused on progressing first- or best-in-class oncology drugs. Ellipses’ maturing clinical pipeline is progressing three clinical phase-2 programmes with an additional programme due to commence Phase 1 studies in 2026.
Ellipses is supported by a global Scientific Advisory Group comprising over 300 leading Oncology Key Opinion Leaders to de-risk initial asset selection and provide critical insights into clinical trial design.
The Role
Ellipses, driven by a robust pipeline of strong clinical candidates, is at an exciting stage of its evolution that promises business growth and the swift delivery of innovative medicines to patients.
As part of this transformation and reporting to the head of QA, we are seeking a highly motivated and experienced Quality Assurance Project Manager with strong operational global GCP experience and GMP exposure, who will be responsible for the planning, co-ordinating and the efficient execution of QA related activities including audit scheduling and review, CAPA review, management of quality investigations, Veeva Basics management maintenance, document filing and management, report and dashboard creation, management and maintenance.
Responsibilities
- Provide QA related support to all functions to ensure full success of the company’s portfolio and regulatory milestones
- Provide QA review and input to quality matters, internally and externally to ensure adherence to our regulatory obligations and maintain patient safety and data integrity during clinical trial life cycle
- Ensure clinical trials are performed in accordance with global regulatory requirements and Ellipses policies, practices and procedures
- Support the Management of the company Quality Management System (QMS) via Veeva, to ensure controlled documents and training requirements are reviewed and updated within relevant timeframes
- Manage the creation of asset audit programmes and ensure all audits are performed with the required timelines. Peer review of audit plans, reports and findings prepared by QA contractors in alignment with corporate SOPs and are tracked to completion using Veeva
- Create and maintain QA reports (e.g. audit responses and CAPAs, Deviations and Investigations) as needed, ensuring they are up-to-date and accurate
- Ensure QA awareness on key regulatory requirement changes (e.g. US CFR, EUCTD, ICH and any other local country requirements) to support evolving compliance in support of active clinical trials
- Support the management of Veeva QMS modules (Documents workspace, Quality Events, Audit and Organisation etc) based on business needs
Role Requirements
- Degree in life sciences, including pharmacy, chemistry, or other equivalent qualifications
- A minimum of five years of experience in the pharmaceutical industry including with early phase clinical trials, preferably within growth phase biotech's, of which a minimum of three must be within GCP QA together with some GMP exposure
- Robust understanding and knowledge of global regulatory and compliance requirements for clinical research, including but not limited to UK Statutory instruments, US CFR, EUCTD, and GXPs. Awareness of other local country requirements (outside the UK, US and EMA is also required)
- Proven experience of having implemented or worked on quality systems using an electronic quality management system (eQMS) such as Veeva Quality Docs, Vault Training and QMS
- Excellent interpersonal communication skills, both in visual presentations and in working 1:1 and with functional teams on quality matters
- Involvement in Regulatory Inspections with the MHRA, EMA and FDA
- Involvement during in and out licensing due diligence activities from a QA perspective
- Involvement in serious beach and scientific misconduct investigations
- High calibre individual, driven and passionate about the importance and impact of quality standards in oncology drug development
- Demonstrated ability to act as a role model for a culture of quality with high levels of integrity and ethical standards
- Seeks practical/workable and innovative methods to deliver solutions and make sound decisions
- Ability to work both independently and in collaboration with other functional team particularly with the clinical development team colleagues
- Ability to plan, manage, prioritise multiple projects and work well under pressure and time constraints
- Proactively demonstrates a desire to enhance and develop their job knowledge
- Willing to travel in UK and abroad if required
Ellipses Pharma is an organisation that values the strength of collaboration, inclusive and quick decision making, knowledge sharing and a culture built on working together on site. As a small but growing company face to face interaction is highly valued.
We recognise that a more hybrid approach is at times required and we do support some element of remote working where operationally appropriate to help employees with work life integration.
By balancing in-person presence with occasional remote working, we ensure we remain agile while protecting the unique benefits that come from working side by side.
Candidates must be able to demonstrate global operational GCP experience and some GMP to be considered for this exciting role.
#LI-PE1
