Quality Assurance Project Manager – Good Clinical Practice (with GMP awareness)

Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.

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, we are seeking a highly motivated and experienced Quality Assurance 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 Vault management maintenance, document filing and management, spreadsheet creation, management and maintenance. The role supports QA activity across the business but will work most closely with the Clinical Operations team.

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  

· Manage the company Quality Management System (QMS), to ensure controlled documents and training requirements are reviewed and updated within relevant timeframes

· Peer review of audit plans, reports and findings prepared by QA contractors in alignment with corporate SOPs and are tracked to completion.

· Maintain and create QA tracking systems (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 development, management and implementation of Veeva QMS modules based on business needs.

Role Requirements

· Degree in life sciences, including pharmacy, chemistry, or other equivalent qualifications

· A minimum of ten years of experience in the pharmaceutical industry including with early phase clinical trials, preferably within growth phase biotech's, of which a minimum of eight 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 maintained 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 and 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

Candidates must be able to demonstrate global operational GCP experience and some GMP to be considered for this exciting role.

Please send your CV and cover letter to