[Hiring] Compliance QA Specialist @Carbyne

Role Description

The Compliance QA Specialist is a key member of the central Quality and Audit organization, responsible for overseeing GxP compliance across global manufacturing sites, monitoring regulatory trends, and supporting health authority inspections. This role acts as a bridge between global quality expectations and local operational execution within a complex pharmaceutical production environment.

• Provide expert support to global pharmaceutical manufacturing sites and internal projects to ensure ongoing GxP compliance.
• Ensure alignment with global QMS requirements.
• Actively participate in the preparation and execution of international health authority inspections (e.g., FDA, EMA).
• Contribute to the development of responses, corrective actions, and remediation plans.
• Plan and execute internal GxP audits across manufacturing operations.
• Participate in the corporate auditor program, including occasional external audits.
• Continuously track changes in the pharmaceutical regulatory landscape.
• Perform gap assessments and propose updates to the global QMS.
• Design, document, and harmonize global quality processes and workflows across manufacturing sites.
• Collect, analyze, and report compliance KPIs to Quality leadership.

Qualifications

• 5–10 years of relevant pharmaceutical industry experience in Quality Assurance or Compliance, in a manufacturing environment.
• Strong knowledge of cGMP regulations (FDA 21 CFR, EU GMP Annexes).
• Experience with quality systems and software (e.g., TrackWise, SAP, or similar document management systems).
• Operational experience in pharmaceutical manufacturing is an advantage.

Benefits

• Option for full remote work or hybrid setup based on candidate preference.
• Transparent, people-focused culture with strong emphasis on work–life balance.
• Opportunity to participate in global compliance initiatives and gain international lead auditor experience.
• A solid, internationally recognized company with a strong growth trajectory.

Company Description