Quality Control Leader — GMP, Compliance & CI

AstraZeneca GmbH; Bogart (GA); On-site; USD 113,000 - 169,000; Full time

Job summary

AstraZeneca GmbH in Georgia (Bogart) seeks a QC Leader to direct Quality Control activities across microbiological and analytical testing. You will oversee personnel, budget, testing strategies, and contract lab involvement while driving compliance and microbial control.

The role requires a strong background in GMP laboratories, leadership of cross-functional teams, and a focus on Lean practices and continuous improvement. Experience in biotech/pharma environments is essential.

Qualifications

• Bachelor’s degree in biological/chemical sciences or related field.
• 10+ years in GMP laboratory environment.
• Experience leading cross-functional teams.
• Lean laboratory practices (5S, visual management, paperless).
• Auditing experience.
• Strong communication with senior management.
• Experience in regulated biotech/pharma environments.

Responsibilities

• Lead QC operations to ensure compliant, efficient, and safe lab activities.
• Manage QC teams supporting in-process testing and CLO testing.
• Oversee lab scheduling to meet regulatory, quality, and business requirements.
• Ensure validation and qualification of test methods and instruments.
• Maintain inspection readiness and represent QC during audits and regulatory interactions.
• Lead QC risk assessments and ensure timely mitigation actions.
• Direct the environmental monitoring program with Manufacturing.
• Drive analytical method transfers and CLO insourcing.
• Lead recruitment, development, and performance management of QC staff.
• Oversee the QC training strategy and retraining programs.
• Provide QC support for investigations and CAPAs, with timely reporting.
• Lead communication and task prioritization within QC for commercial operations.
• Ensure timely testing and data review/approval for batch disposition.
• Support APQR process and process monitoring activities.
• Build continuous improvement capability within QC, including AI.

Skills

GMP laboratory experience

People leadership

Cross-functional collaboration

Lean lab practices

Project management

Auditing

Regulatory knowledge

Problem solving

Education

Bachelor’s degree in Biological/Cood chemical sciences or related field

Job description

AstraZeneca GmbH in Georgia (Bogart) seeks a QC Leader to direct Quality Control activities across microbiological and analytical testing. You will oversee personnel, budget, testing strategies, and contract lab involvement while driving compliance and microbial control.

The role requires a strong background in GMP laboratories, leadership of cross-functional teams, and a focus on Lean practices and continuous improvement. Experience in biotech/pharma environments is essential.