QA Lead, Life Sciences & CDMO Partnerships

ProPharma; United Kingdom; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

ProPharma is seeking a Quality Assurance Lead to support Person-In-Plant activities across CDMO partners in the EU. The role is a short-term engagement starting immediately with 1.0 FTE (40 hours/week) and travel to UK/EU sites for two to three weeks at a time.

You will lead QMRs, oversee PPQ activities, coordinate audits, and drive inspection readiness while ensuring GMP compliance and alignment with ProPharma standards.

Qualifications

• Must be educated to a BSc or higher within a life-sciences discipline.
• Thorough experience working in Quality Assurance within the Life-sciences industry.
• Previous experience either working as a Person-in-Plant or supporting them is key for success.
• Previous experience managing CDMO partners would be highly preferred.
• Fluent in English.
• Currently based within the UK or EU.
• Can perform the project as designated within the job description.

Responsibilities

• Lead and manage routine Quality Management Reviews (QMRs).
• Provide quality oversight and support during Process Performance Qualification (PPQ) activities for both clinical and commercial products, ensuring compliance with applicable quality and regulatory requirements.
• Act and perform key audits related to these findings.
• Coordinate and deliver mock inspection readiness activities, including preparation, coaching, documentation review, and support for inspection simulations.
• Perform a variety of QMS tasks which includes CAPAs, deviations etc.
• Support inspection and audit readiness initiatives across clinical and commercial manufacturing operations.
• Collaborate with cross-functional stakeholders to ensure quality risks are addressed and resolved.
• Review and evaluate quality systems, documentation, and manufacturing activities to ensure alignment with GMP requirements and company quality standards.
• Act as a quality subject matter expert for assigned projects and quality-related initiatives, providing guidance on compliance expectations and quality system requirements.
• Overall key support to all Person-In-Plant activities from a QA Lead perspective

Skills

Quality Assurance

GMP

QA Lead

Audits

QMS

CAPA

Inspection readiness

Cross-functional collaboration

English fluency

Education

BSc or higher in Life Sciences

Job description

ProPharma is seeking a Quality Assurance Lead to support Person-In-Plant activities across CDMO partners in the EU. The role is a short-term engagement starting immediately with 1.0 FTE (40 hours/week) and travel to UK/EU sites for two to three weeks at a time.

You will lead QMRs, oversee PPQ activities, coordinate audits, and drive inspection readiness while ensuring GMP compliance and alignment with ProPharma standards.