Sterility Assurance Project Lead – GMP & Regulatory

CSL Vifor; Liverpool; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

CSL Vifor is seeking a senior sterility assurance project lead to manage high-complexity site initiatives, including the implementation and qualification of new filling lines and related changes. You will define strategies, coordinate stakeholders, and ensure technical feasibility while tracking resources, timelines, and budgets.

The role requires extensive GMP and regulatory experience, plus proven ability to work within a global matrix organization, manage deviations, and support inspections

Qualifications

• Bachelor’s degree in a life sciences field or equivalent relevant field. An advanced degree is preferred.
• 7+ years of pharmaceutical manufacturing experience with GMP in regulated industries.
• Experience with regulatory authorities, submissions, and inspections.
• Experience in a global matrix organization and project management.

Responsibilities

• Stability and sterility assurance projects for high-complexity site initiatives.
• Lead implementation and qualification of new filling lines and engineering changes.
• Develop project strategy, scope, objectives, and ensure feasibility with stakeholders.
• Predict resources, monitor progress, timelines and budget.
• Coordinate deviations, product complaints, and remedial actions.
• Support regulatory inspections, self-inspections, and customer audits.
• Generate and review project documentation.

Skills

Project management

Regulatory inspections

GMP experience

QA systems

Auditing practices

Cross-functional coordination

Regulatory affairs

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or life sciences; advanced degree preferred

Job description

CSL Vifor is seeking a senior sterility assurance project lead to manage high-complexity site initiatives, including the implementation and qualification of new filling lines and related changes. You will define strategies, coordinate stakeholders, and ensure technical feasibility while tracking resources, timelines, and budgets.

The role requires extensive GMP and regulatory experience, plus proven ability to work within a global matrix organization, manage deviations, and support inspections