Hybrid: Validation & Quality Systems Leader (Pharma)

Biopharma Careers; Zebulon (GA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

GSK is seeking a senior-level Validation leader to drive the Validation Life Cycle, Change Control, and associated programs across manufacturing and labs. The role requires advanced expertise in chemical theory, analytical methods, and laboratory instrumentation within a GMP framework.

You will Develop and maintain the Validation Master Plan, lead cross-functional teams, and coordinate with IT and EIS to ensure uninterrupted services and compliant processes.

Qualifications

• Bachelor's degree (BS) or equivalent in Chemistry, Engineering, Quality, Pharmaceutical Operations, or a related field.
• Minimum 10 years of experience in the pharmaceutical industry (15 years preferred).
• Minimum 7 years of validation experience in manufacturing or development (10 years preferred).
• Experience with analytical equipment and analytical method validation.
• Proven experience managing validation projects, including capital projects.
• Experience leading validation teams or high-paced operational/quality-focused teams.
• Background in laboratory operations, laboratory applications, or IT within a scientific environment.
• Strong technical expertise in chemical theory, analytical methodologies, laboratory and microbiological instrumentation, and computer applications related to pharmaceutical analysis.

Responsibilities

• Drive all aspects of Validation Life Cycle and Change Control.
• Develop and maintain the Validation Master Plan.
• Define and optimize validation strategies for product, process, facilities, and cleaning; include change control.
• Oversee validation protocols for facility services, equipment, and laboratory systems.
• Lead analytical method transfer activities and cleaning validation programs.
• Provide validation technical assistance across organizations when needed.
• Coordinate with business units to align validation activities with objectives.
• Collaborate with Global/Regional service providers to meet requirements.

Skills

Analytical thinking

Project management

Leadership

GMP compliance

Validation management

Education

Bachelor's degree in Chemistry/Engineering/Quality/Pharmaceutical Operations

Job description

GSK is seeking a senior-level Validation leader to drive the Validation Life Cycle, Change Control, and associated programs across manufacturing and labs. The role requires advanced expertise in chemical theory, analytical methods, and laboratory instrumentation within a GMP framework.

You will Develop and maintain the Validation Master Plan, lead cross-functional teams, and coordinate with IT and EIS to ensure uninterrupted services and compliant processes.