Regulatory Compliance Lead

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

Position Summary

This role leads a team of professionals acting as advisor, facilitator, and team member regarding regulatory compliance and pertinent quality systems for all aspects of the manufacturing, testing, storage and distribution of pharmaceutical products. The incumbent will provide guidance and training to new and existing employees, assist them with decision making, and lead regulatory compliance activities across US operations. You will work with quality, manufacturing, and technical teams to ensure compliance with regulations and company standards, building a proactive compliance culture and driving measurable impact on patient safety and public health.

Responsibilities

Lead key activities to progress regulatory compliance programs and ensure alignment with US and global regulatory requirements.

• Support inspection readiness including responses to regulatory authority requests and audits.
• Manage regulatory risk assessments and drive corrective and preventive actions to closure.
• Collaborate with cross‑functional teams to implement compliance plans and improve processes.
• Prepare clear reports and metrics for leadership on compliance status and improvement initiatives.
• Coach and influence colleagues to build a proactive compliance culture across the organization.
• Ensure all proposed technical changes are properly assessed via the Change Control System and provide guidance on regulatory impact.
• Represent the site in meetings requiring regulatory input and updates (e.g., PTRT, CoPs, Change Control Panel).
• Manage the implementation of registered commitments to ensure continuous compliance and success in global regulatory authority inspections (e.g., FDA).
• Coordinate efforts with GSK Regulatory Affairs, LOCs and other business departments to maintain current mandatory licenses and registrations.
• Oversee the management of Quality Agreements and Quality Agreement Product Requirements Specifications for API’s supplied to Zebulon and other contract manufacture products.
• Supervise employees related to the management of regulatory compliance and quality systems using established procedures and guidelines.
• Accountable for employee development and/or performance management through assignments and technical training programs; coach direct reports.
• Support the Quality Compliance Director with succession planning, team objectives, and implementation of new departmental strategies.
• Act as single point of accountability for site regulatory compliance, encouraging strategic decision making to drive compliance for all new and existing products.
• Manage the Periodic Product Review (PPR) Program for the site.

Basic Qualifications

• 8+ years’ experience in a cGMP environment, with 5+ years in regulatory affairs or a quality/regulatory compliance role.
• Minimum 2 years as a people leader.
• BS or BA in a relevant technical discipline (life sciences, engineering, regulatory affairs, or related field), or equivalent experience.
• Demonstrated experience with GMPs, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions and compliance.
• Demonstrated experience with GMP’s, NIH Guidelines, FDA and other regulatory agency requirements preferred.
• Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Experience supporting regulatory inspections and audit activities; strong knowledge of US regulatory requirements and good manufacturing practices.

Preferred Qualifications

• Advanced degree in a relevant scientific or technical discipline.
• Good written communication, organizational, and computer skills; ability to prioritize and decide on appropriate actions.
• Ability to interact with peers, subordinates and senior personnel in multidisciplinary environments including engineering, facility operations, validation, production and QC.
• Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Good understanding and interpretation of global regulations pertaining to the manufacture, holding and distribution of human drug products.
• Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers.
• Proven ability to lead cross‑functional projects and influence stakeholders.
• Excellent written and verbal communication skills with attention to detail.
• Experience with global regulatory interactions and harmonization activities.
• Experience coaching teams and building compliance capability.
• Familiarity with quality management systems and trending tools.
• Experience writing regulatory submissions or formal responses to authorities.
• Prior experience in continuous improvement or operational excellence programs.

Work Arrangement

This role is hybrid. You will be expected to work on‑site regularly, with flexibility for remote work as agreed with your manager.

What you can expect from us

We value inclusion, clear communication and practical action. We support learning and career development and welcome diverse perspectives to help us do the right thing for patients safely and reliably.

Ready to apply?

If this role fits your experience and ambitions, please submit a concise summary of how your background matches the basic qualifications and a short example of a compliance challenge you led.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.