Quality Tech & Validation Leader – GMP/GxP

GlaxoSmithKline; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

GSK US is seeking a Quality Technical and Validation Manager to lead validation and qualification activities across GMP environments. You will drive process and equipment lifecycle programs, ensuring compliance with regulatory standards and GSK quality practices.

The role leads a site quality team and interfaces with regulators, R&D, MSAT, and analytical groups to accelerate compliant product transfers and continuous improvement.

Qualifications

• Bachelor’s degree in a scientific/engineering discipline.
• 10+ years in pharma/biotech with decision accountability.
• 5+ years in leadership roles and teams.

Responsibilities

• GxP oversight of validation and qualification activities across processes, equipment and facilities.
• Define phase-specific controls for production and lab value streams.
• Oversee NPI tech transfer reviews and approvals per standards.
• Develop and approve equipment validation protocols for services and systems.
• Determine change control requirements for validation and qualification.
• Ensure validation activities comply with GSK quality standards and regulatory requirements.
• Collaborate with R&D, MSAT/validation, and Product Quality Leads on transfer strategies.
• Monitor validation data and identify trends for improvement.
• Support internal/external audits and regulatory inspections on validation matters.

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 in a relevant scientific or engineering discipline

5+ years leadership experience

10+ years pharmaceutical/biotech experience

Job description

GSK US is seeking a Quality Technical and Validation Manager to lead validation and qualification activities across GMP environments. You will drive process and equipment lifecycle programs, ensuring compliance with regulatory standards and GSK quality practices.

The role leads a site quality team and interfaces with regulators, R&D, MSAT, and analytical groups to accelerate compliant product transfers and continuous improvement.