Quality Systems Manager

Proclinical is seeking a Quality System Manager to help globalise QA processes. This role involves the development and maintenance of quality processes within the organisation. The Quality System Manager will be responsible for ensuring the compliance of all pharmaceutical processes with GxP and applicable national and international regulatory guidelines. This role requires excellent knowledge of quality regulations in the US and EEA.

Responsibilities:

• Maintenance of company QA documentation in accordance with applicable regulations.
• Management of QA documentation processes including writing, review, signature, distribution and acknowledgment.
• Collection and implementation of training requirements to SOPs from process owners.
• Issuance of periodical KPIs and metrics to measure trends and performance of the QA documentation system.
• Ownership and administration of the EDMS database.
• Maintenance of the QA system related to Complaints, Deviation, CAPA and Change controls processes.
• Management of the Quality Officers including setting up objectives, evaluations and finalization of PDP.

Key Skills and Requirements:

• A degree in pharmacy, chemistry, or another Life Sciences qualification.
• Previous significant experience in equivalent roles, such as a pharmaceutical quality assurance role within a work-place environment.
• Strong knowledge of GxP such as GDP, GMP, GVP.
• Proven experience of having implemented or maintained quality systems using an electronic quality management system (QMS).
• Strong Agile thinker who can adapt to situations of high-speed change.
• Problem solver who can work through complex issues.
• Candidate must demonstrate a Growth mindset and willingness to learn.
• Must demonstrate integrity and high ethical standards.
• Previous demonstration of working effectively as part of a team with strong collaboration.
• Demonstrates a willingness to achieve goals together and respect the view of others.
• Results orientated and accountable for actions.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes on I.aymes@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.