Manager, Gxp Quality Systems, Europe

1 month ago


London, United Kingdom Cpl Life Sciences Full time

GxP Quality Systems Manager

12 month FTC

£46,000

UK Remote based
- Coordinate the maintenance of the clients Europe’s core Quality Systems such as GxP Documentation and Training.
- Monitors, evaluates and trends the performance of the respective Quality System Elements and implements any agreed changes with the necessary approvals;
- Oversees the performance of the GxP Quality Management System in order to meet the requirements of the business;
- Implement and refine measures for assessing performance (KPIs) and compliance risk (KRIs).
- Ensuring the compliance of the respective quality systems including supporting CSV with validation deliverables as required.
- Collaborating with Global Quality Systems colleagues to enhance and harmonise quality related processes.
- Working with affiliate offices to ensure alignment and integration of any local QMS systems with the EU and Global QMS. Working on EU Quality Systems projects, and providing support to Global QS projects as needed

**Responsibilities**:

- Implementing, maintaining and improving GxP Quality Systems for Europe.
- Establishment of key metrics, reporting and trending for quality systems.
- Overseeing of the timely completion of GxP records and performance of Quality Systems for Europe.
- Driving compliance within our GxP Quality Systems through effective monitoring and communication.
- Supporting the development of Europe’s SOPs; ensuring documentation development, completion and the ongoing training process.
- Managing and championing documentation and training projects within the QA department.
- Processing administrative changes to Europe’s SOPs.
- Coordinating SOP writing with the other Functional Areas and ensuring this is completed.
- Coordinating all activities associated with SOP training and GxP learning events that are coordinated by the QA & Compliance function, including but not limited to planning, scheduling, material preparation, training record maintenance and reporting.
- Coordinating presentation materials, meeting arrangements and meeting minutes for the Quarterly Quality Management Review meeting.
- Maintaining the online learning management system for Europe.
- Liaising with the all functions to assure matters raised to/with QA & Compliance are timely resolved and tracked to completion.
- Assisting, resolving and looking to continually improve the user experience with Veeva QD/QMS related user issues and evolve the systems to ensure a great user experience.
- Always providing clear and easy to follow QA & compliance communications that translate quality into an understandable user experience.
- Ensuring that the right issues are anticipated and escalated as appropriate
- Assisting in the preparation work for internal/external audits and Competent Authority inspections.
- Assisting and supporting regulatory inspections.
- Assisting as necessary with resolving issues to ensure that priorities, deadlines and quality standards are met and that QA & Compliance reports are collated and submitted in a timely fashion.
- Identifying opportunities for improvement and making fully considered proposals to the rest of the QA team.

Required Skillset
- Proficient in MS Office, MS Excel, MS Access, MS Projects.
- Fluency in English
- Relevant experience gained within a Pharmaceutical Company
- Proven experience in GxP Quality Systems and/or Quality Assurance


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