Compliance Specialist

Job Description

JOB SUMMARY

We are looking for a Quality Compliance Specialist to support quality compliance, inspection readiness, and data integrity activities within a GMP-regulated pharmaceutical manufacturing environment. This role will be responsible for supporting internal audits, regulatory inspections, data integrity programs, and quality systems activities to ensure ongoing compliance with GMP requirements and site quality standards.

The successful candidate will work closely with Quality, Manufacturing, Engineering, Validation, and Compliance teams to maintain inspection readiness, manage quality system activities, and promote a strong quality culture across the site. This position requires strong knowledge of GMP manufacturing operations, data integrity principles, and quality compliance processes within pharmaceutical or biologics manufacturing environments.

About The Job

• Serve as the Compliance Partner for assigned departments, supporting inspection readiness initiatives and continuous compliance improvement activities
• Support regulatory inspections and external audits through logistics coordination, backroom support, documentation management, and stakeholder coordination
• Conduct site-wide Data Integrity training programs, including refresher training and new employee onboarding sessions Review and support Data Integrity documentation, including Audit Trail Reviews, Data Integrity Risk Assessments (DIRA), and related compliance activities
• Conduct internal GMP audits and support audit lifecycle activities, including CAPA follow-up, response discussions, and management of open audit actions
• Support Quality Risk Management (QRM), Quality Management Review (QMR), Quality Plan, and Regulatory Submission activities through task coordination and follow-up
• Review, revise, route, and maintain quality system documentation in accordance with site procedures and GMP requirements
• Collaborate with Manufacturing, Engineering, Validation, Quality Assurance, and other cross-functional teams to ensure compliance with quality and regulatory expectations
• Support the management and tracking of quality actions, commitments, CAPAs, and compliance-related deliverables to ensure timely completion
• Promote quality culture, compliance awareness, and data governance practices across the manufacturing site

About You

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, Chemistry, or related disciplines
• At least 6 years of Quality Assurance experience within GMP-regulated pharmaceutical, biologics, or API manufacturing environments
• Experience in Quality Operations, Quality Compliance, or related GMP quality functions is preferred
• Experience supporting internal audits, regulatory inspections, and inspection readiness activities is preferred
• Strong knowledge of GMP requirements, Quality Systems, CAPA management, and compliance processes
• Good understanding of Data Integrity principles, Data Governance, Audit Trail Review, and Data Integrity Risk Assessment methodologies
• Familiarity with manufacturing and laboratory computerized systems such as DeltaV, MES, SAP, LIMS, or related GMP systems is preferred
• Understanding of engineering operations, OT/IT systems, and system interfaces within regulated manufacturing environments is advantageous
• Strong communication, technical writing, stakeholder management, and training delivery skills
• Highly adaptable with the ability to work effectively across multiple functions and manage competing priorities
• Team-oriented mindset with a strong commitment to quality, compliance, and continuous improvement