Regulatory Compliance Lead — GMP, FDA & Audits

GlaxoSmithKline; Zebulon (NC); Hybrid; USD 100,000 - 130,000; Full time

Job summary

GlaxoSmithKline is seeking a Regulatory Compliance Lead in Zebulon, NC, to lead a team ensuring compliance within manufacturing and distribution of pharmaceuticals. The role involves guiding regulatory activities and employee training while fostering a culture of compliance.

The ideal candidate will have over 8 years of experience, significant leadership in regulatory affairs, and a degree in life sciences, engineering, or related fields. The position offers a hybrid work environment to balance onsite and remote work.

Qualifications

• 8+ years’ experience in a cGMP environment, with 5+ years in regulatory affairs or quality/regulatory compliance.
• Minimum 2 years as a people leader.
• Demonstrated experience with GMPs, FDA, and other regulatory agency requirements.

Responsibilities

• Lead key activities to progress regulatory compliance programs.
• Support inspection readiness and manage regulatory risk assessments.
• Collaborate with cross-functional teams to improve processes.

Skills

Regulatory Compliance

cGMP knowledge

Leadership

Quality Systems Management

Communication Skills

Education

BS or BA in a relevant technical discipline

Job description

GlaxoSmithKline is seeking a Regulatory Compliance Lead in Zebulon, NC, to lead a team ensuring compliance within manufacturing and distribution of pharmaceuticals. The role involves guiding regulatory activities and employee training while fostering a culture of compliance.

The ideal candidate will have over 8 years of experience, significant leadership in regulatory affairs, and a degree in life sciences, engineering, or related fields. The position offers a hybrid work environment to balance onsite and remote work.