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Senior Quality GMP Manager at LinkedIn

London, Essex - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

10 Nov, 26

Salary

55000.0

Posted On

05 Oct, 26

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Key responsibilitiesLead GMP and Quality readiness activities across Manufacturing, QC, Engineering and Regulatory interfaces
Drive gap assessment, remediation and closure of Quality risks
Strengthen QMS processes including deviations, CAPA, change control, investigations, training and documentation
Provide Quality oversight for validation and technology-transfer activities
Support FDA PAI readiness, mock inspections and SME preparation
Monitor Quality risks, actions and readiness status and report to programme leadership
Key deliverablesGMP/QMS readiness assessment
Prioritised remediation plan
Manufacturing and QC readiness review
Validation and technology-transfer Quality oversight
FDA PAI readiness plan
Mock inspection and follow-up action plan
SME coaching and inspection preparation
Quality readiness dashboard and final readiness assessment
ProfileSenior Quality professional with strong experience in pharmaceutical finished products
Solid EU GMP and FDA knowledge
Proven experience in inspection readiness, remediation and Quality Systems
Strong leadership and cross-functional stakeholder management

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Responsibilities