Senior Quality Lead, Life Sciences (CDMO/PIP)

ProPharma Group; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

ProPharma Group is seeking a QA Lead to support Person-In-Plant activities across UK/EU CDMO partners. The role is 1.0 FTE with travel to sites for several weeks and offers hybrid working. It requires quality leadership across GMP/QA activities and inspection readiness support.

Responsibilities include QMRs, PPQ support, audits, CAPAs, and cross-functional collaboration. Fluent English and a life-sciences background are essential for success.

Qualifications

• Must have a BSc or higher within a life-sciences discipline.
• Thorough experience working in Quality Assurance within the Life-sciences industry.
• Experience as Person-in-Plant or supporting them is key for success.
• Experience managing CDMO partners would be highly preferred.
• Fluent in English.
• Currently based within the UK or EU.

Responsibilities

• Lead and manage routine Quality Management Reviews (QMRs).
• Provide quality oversight during Process Performance Qualification (PPQ) activities for clinical and commercial products.
• Act and perform key audits related to findings.
• Coordinate mock inspection readiness activities and simulations.
• Perform QMS tasks including CAPAs and deviations.
• Support inspection and audit readiness across clinical and commercial manufacturing.
• Collaborate with cross-functional stakeholders to address quality risks.
• Review production documentation to ensure GMP compliance.
• Provide QA SME guidance on quality systems and project initiatives.

Skills

QA in Life Sciences

Person-in-Plant experience

CDMO partner management

GMP/QMS knowledge

English fluency

UK/EU based

Education

BSc or higher in Life Sciences

Job description

ProPharma Group is seeking a QA Lead to support Person-In-Plant activities across UK/EU CDMO partners. The role is 1.0 FTE with travel to sites for several weeks and offers hybrid working. It requires quality leadership across GMP/QA activities and inspection readiness support.

Responsibilities include QMRs, PPQ support, audits, CAPAs, and cross-functional collaboration. Fluent English and a life-sciences background are essential for success.