GMP Compliance Lead — QA, Audits & CAPA

Experis Technology Group; Durham (NC); On-site; USD 53,000 - 76,000; Full time

Job summary

Experis Technology Group seeks an experienced GMP Compliance Leader to provide strategic and operational QA support across pharmaceutical/biotech operations. You will partner with Quality Management, QA, CMC, Supply Chain, and cross-functional teams to maintain regulatory compliance and drive quality improvements.

The role focuses on batch disposition, deviations, CAPA, change control, audits, and regulatory inspections, with strong collaboration across internal and external stakeholders.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related discipline.
• Experience in Quality Assurance, GMP compliance, or Quality Management within pharmaceutical/biotech.
• Hands‑on experience with deviations, investigations, CAPA, and change control.
• Experience supporting GMP audits and regulatory inspections.
• Knowledge of batch disposition, product quality, and pharmaceutical manufacturing processes.
• Understanding of CMC, pharmaceutical supply chain, and quality management systems.
• Knowledge of applicable regulatory requirements, ICH guidelines, GxP, and SOPs.
• Strong communication, analytical, problem‑solving, and stakeholder management skills.

Responsibilities

• Support and perform batch disposition activities and product quality complaint investigations.
• Lead and manage deviations, quality events, root cause investigations, and CAPA activities.
• Oversee and support change control processes and quality improvement initiatives.
• Lead, coordinate, and participate in GMP audits and regulatory inspections.
• Provide Quality Assurance support to CMC, manufacturing, and Supply Chain functions.
• Partner with internal stakeholders and external vendors to ensure ongoing GMP compliance.
• Identify quality risks, recommend mitigation strategies, and escalate significant compliance issues.
• Maintain accurate quality documentation in accordance with GMP regulations and internal SOPs.
• Support the implementation of Quality Management Plans and Risk Management Programs.
• Provide guidance on quality systems, regulatory requirements, and compliance best practices.
• Prepare quality reports, risk assessments, and updates for business stakeholders.

Skills

Quality Assurance

GMP compliance

CAPA management

Audit coordination

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related discipline

Job description

Experis Technology Group seeks an experienced GMP Compliance Leader to provide strategic and operational QA support across pharmaceutical/biotech operations. You will partner with Quality Management, QA, CMC, Supply Chain, and cross-functional teams to maintain regulatory compliance and drive quality improvements.

The role focuses on batch disposition, deviations, CAPA, change control, audits, and regulatory inspections, with strong collaboration across internal and external stakeholders.