Regulatory Compliance Leader - Pharma Quality & Audits

Biopharma Careers; Zebulon (GA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

GSK in Zebulon, GA is seeking a senior regulatory compliance leader to guide the site’s quality systems and regulatory activities. You will partner with QA, manufacturing, and technical teams to ensure compliance with US and global requirements and lead inspection readiness and responses.

You will coach teams, drive continuous improvement, and manage regulatory risk while ensuring alignment with corporate strategies and product commitments.

Qualifications

• Bachelor-level degree in a relevant technical field; advanced degree preferred.
• Experience with GMPs, FDA/EMA/MHRA regulatory requirements.
• Proven ability to lead regulatory inspections and audits.

Responsibilities

• Lead regulatory compliance programs across US operations.
• Provide guidance/training on quality systems and decision making.
• Coordinate with QA, manufacturing, and technical teams for compliance.
• Ensure readiness for regulatory inspections and issue responses.
• Oversee Change Control and regulatory submissions impact assessments.

Skills

Regulatory leadership

GxP compliance

People management

Cross-functional collaboration

Education

BS/BA in life sciences or related field

Advanced degree preferred

Tools

Quality Management Systems

Job description

GSK in Zebulon, GA is seeking a senior regulatory compliance leader to guide the site’s quality systems and regulatory activities. You will partner with QA, manufacturing, and technical teams to ensure compliance with US and global requirements and lead inspection readiness and responses.

You will coach teams, drive continuous improvement, and manage regulatory risk while ensuring alignment with corporate strategies and product commitments.