GxP Quality Tech & Validation Leader

Biopharma Careers; Marietta (GA); On-site; USD 150,000 - 185,000; Full time

Job summary

GSK seeks a Quality Technical and Validation Manager to lead validation oversight across manufacturing and analytical environments. You will ensure GxP compliance, manage change controls, and collaborate with cross-functional teams for efficient technology transfer and product introductions.

The role emphasizes leadership, regulatory knowledge (FDA/EMA/ICH), and strong analytical skills to maintain high GMP standards across the site and network.

Qualifications

• Bachelor’s degree in a relevant scientific or engineering discipline.
• Advanced degree in a relevant field preferred.
• Experience in validating processes and equipment in pharma/biotech.

Responsibilities

• Provide GxP oversight for validation and qualification activities across processes, equipment, and systems.
• Manage New Product Introductions (NPI) and tech transfer with regulatory alignment.
• Develop and approve validation protocols and change control documents.
• Collaborate with R&D, MSAT, Product Quality Leads to rapid product transfers.
• Monitor validation data, identify trends, and drive continuous improvement.
• Support internal/external audits and inspections with QA expertise.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor's degree

Advanced degree (Master's/PhD)

Job description

GSK seeks a Quality Technical and Validation Manager to lead validation oversight across manufacturing and analytical environments. You will ensure GxP compliance, manage change controls, and collaborate with cross-functional teams for efficient technology transfer and product introductions.

The role emphasizes leadership, regulatory knowledge (FDA/EMA/ICH), and strong analytical skills to maintain high GMP standards across the site and network.