Quality Control Leader - GMP & Compliance

Alexion Pharma Spain S.L.; Georgia; On-site; USD 113,000 - 169,000; Full time

Benefits offered by this job

Incentives

Retirement plan

Paid time off

Health insurance

Job summary

Alexion Georgia Manufacturing Facility in Bogart, Georgia, seeks a Quality Control Manager to lead all QC activities, oversee microbiological and analytical testing, and manage contract testing. The role drives the QC strategic roadmap for business continuity, risk mitigation, continuous improvement, and regulatory compliance.

The candidate will lead a matrix team, ensure inspection readiness, manage budgets, and advance quality systems while deploying Lean practices and AI-enabled improvements

Qualifications

• Bachelor’s degree or equivalent in biological/chemical sciences, business, or technical field.
• 10+ years of GMP laboratory experience.
• Proven ability to build and mentor high-performing teams.
• Experience in a matrix organization.
• Knowledge of Lean lab practices (5S, visual management).
• Auditing experience in regulated environments.

Responsibilities

• Lead QC operations to ensure compliant, efficient, and safe laboratory activities with testing, Lean, and safety standards.
• Oversee QC laboratory teams supporting in-process testing, microbiological support, and CLO testing.
• Manage lab scheduling to meet regulatory, quality, and business requirements.
• Ensure validation and qualification of test methods and instruments for in-process and release testing.
• Maintain inspection readiness and represent QC during audits and regulatory interactions.
• Lead QC risk assessments and implement mitigation actions.
• Direct environmental monitoring program with Manufacturing for robust processing and monitoring.
• Drive method transfers and CLO insourcing to support transgenic roadmap and continuity.
• Lead recruitment, development, and performance management of QC staff.
• Oversee QC training strategies including development, delivery, and retraining.

Skills

People leadership

Lean Laboratory

Regulatory knowledge

Auditing

Project management

Cross-functional collaboration

Communication

Education

Bachelor's degree in biological/chemical sciences or related field

Experience in regulated industry

Tools

Quality systems

cGMP environment

Job description

Alexion Georgia Manufacturing Facility in Bogart, Georgia, seeks a Quality Control Manager to lead all QC activities, oversee microbiological and analytical testing, and manage contract testing. The role drives the QC strategic roadmap for business continuity, risk mitigation, continuous improvement, and regulatory compliance.

The candidate will lead a matrix team, ensure inspection readiness, manage budgets, and advance quality systems while deploying Lean practices and AI-enabled improvements