Senior QA Specialist – Supplier Quality

About the role

The Senior QA Specialist, Supplier Quality joins Bionova Scientific’s Quality Assurance Compliance team to oversee supplier qualification and ensure GMP compliance across the supply chain. This hybrid position blends independent analysis with collaborative interaction with internal and external partners.

Key responsibilities

• Assess potential suppliers by reviewing quality systems, manufacturing processes and capabilities to ensure compliance with GMP standards.
• Lead on‑site audits of supplier facilities and manage change control, discrepancy investigations and supplier corrective actions.
• Maintain and negotiate quality agreements, monitor supplier performance metrics and drive continuous improvement.
• Support Bionova’s self‑inspection program, client audits, health‑authority inspections and preparation of regulatory readiness.

Required profile

• Bachelor’s degree in a scientific discipline with at least 10 years of GMP Quality Assurance experience.
• Proven ability to work independently and collaboratively in a hybrid environment, with strong written and verbal communication.
• Experience managing supplier qualification programs and conducting supplier investigations.

Required skills

• GMP Quality Assurance and Quality Systems knowledge (21 CFR 210/211/11, ICH, Annex 1).
• Proficiency with ERP and electronic QMS (eQMS) platforms.
• Data analysis and trend analysis for quality metrics.
• Understanding of pharmaceutical manufacturing processes and documentation requirements.