Quality assurance manager Work, Jobs in Maida Hill, Gtl (with Salaries)

Quality Manager - GCP (with GMP awareness)
Ellipses Pharma —London
- Project management
- Travel
- Communication skills
8d
Manager, Quality Assurance
LSEG (London Stock Exchange Group) —London
- Full-time
- Management
- Computer Science
- DevOps
14d
Manager Quality Operations
McDermott —London
- Full-time
- Bachelor's degree
10d
Test Lead
HCLTech —London
4d
Curriculum and Quality Manager
Action Tutoring —London
- £37,355 - £39,164 a year
- Full-time
- Hybrid work
- Computer literacy
- Public speaking
- English
- Flexitime
Assistant Head of Quality Assurance (Curriculum Shape)
University of Greenwich —Greenwich
- £46,049 - £56,535 a year
- Call to connect
- University
1h
Quality Assurance Manager
Guildmore Ltd —London
- Full-time
- Microsoft Office
- Contracts
- Construction
Quick apply
Quality & Test Manager
Capgemini —London
- Hybrid work
- Salesforce
- AWS
- Agile
10d
Quality and Risk Manager
Circle Health Group —Windsor
- Full-time
- Hospital
- Data analysis skills
- In-person
- Employee discount
- Life insurance
Quick apply
Quality Assurance Team Manager
Hillingdon Council —Uxbridge
- £53,172 - £57,402 a year
- Analysis skills
- Leadership
- Free parking
- Employee discount
4d
Senior Manager, Lead QA Operations Service Provider
Ipsen Biopharm Ltd —London
- Full-time
- English
- Analysis skills
- Leadership
8d
Associate Quality Lead
Roche —Welwyn
- English
- Bachelor's degree
- Organisational skills
12h
POCT Biomedical Scientist & Deputy Quality Manager
DocTap —London
- £38,000 a year
- Full-time
- Laboratory experience
- Bachelor's degree
- Agile
- Annual leave
Quick apply
2d
Quality & Compliance Manager - 12 Month Fixed Term Contract
Aster Group —St. John's Wood
- £50,000 a year
- Full-time
- Employee assistance programme
10d
Internal Audit Quality Assurance Sr Manager, Digital Transformation
Mars —London
- Bachelor's degree
- Software development
- Accounting
9d
Clinical Quality Assurance - Program Lead (Associate Director)
Novartis —London
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Quality Assurance Manager
New England Seafood International —Chessington
- Full-time
- Management
- Organisational skills
- Employee assistance programme
- Life insurance
Quick apply
Lead Midwife for Quality Governance, Assurance & Compliance
Chelsea and Westminster Hospital NHS Foundation Trust —London
- £75,328 - £86,114 a year
- Full-time
- Gym membership
1d
Quality Manager
Indra Group UK & Ireland —London
- Hybrid work
- Engineering
- Analysis skills
- Bachelor's degree
- Work from home
- Employee assistance programme
Quick apply
Quality and Information Manager
Ferrovial —London
- Full-time
- Bachelor's degree
- Travel
- Organisational skills
8h

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Quality Manager - GCP (with GMP awareness)

Ellipses Pharma
London

Apply Now

Job details

8 days ago

Qualifications

Project management
Quality assurance
Communication skills

Full job description

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

Apply Now

Refine Your Search

quality assurance manager jobs in maida hill, gtl

Quality Manager - GCP (with GMP awareness)

Manager, Quality Assurance

Manager Quality Operations

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Curriculum and Quality Manager

Assistant Head of Quality Assurance (Curriculum Shape)

Quality Assurance Manager

Quality & Test Manager

Quality and Risk Manager

Quality Assurance Team Manager

Senior Manager, Lead QA Operations Service Provider

Associate Quality Lead

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Quality & Compliance Manager - 12 Month Fixed Term Contract

Internal Audit Quality Assurance Sr Manager, Digital Transformation

Clinical Quality Assurance - Program Lead (Associate Director)

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Lead Midwife for Quality Governance, Assurance & Compliance

Quality Manager

Quality and Information Manager

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