Senior Quality Compliance Lead - Supplier QA (Pharma)

Zentiva Poland; Hinoba-an; On-site; PHP 990,000 - 1,650,000; Full time

Job summary

Zentiva Poland seeks a Sr. Executive - Quality Compliance (Supplier Quality Assurance) to lead QA activities across the supplier network, ensuring third‑party suppliers meet GMP, regulatory requirements, and company standards in Ankleshwar.

The role oversees supplier qualification, audits, CAPAs, documentation, and collaboration with procurement, R&D, manufacturing, and regulatory affairs to drive risk‑based improvements across the pharmaceutical supply chain.

Qualifications

• Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
• Experience: 6-8 years in QA/Quality Compliance with at least 2 years in SQA.
• Exposure to regulatory inspections and working with global suppliers is preferred.

Responsibilities

• Lead supplier quality assurance activities to ensure GMP compliance.
• Develop, implement, and maintain supplier quality systems and risk-based assessments.
• Plan, conduct, and follow up supplier audits (on-site and remote).
• Maintain Approved Supplier List and GMP documentation.
• Draft, negotiate, and manage Quality Agreements with suppliers.
• Support regulatory inspections with supplier documentation and data.
• Collaborate with Procurement, R&D, Manufacturing, and Regulatory Affairs for issue resolution and improvements.
• Drive continuous quality improvement and monitor supplier KPIs.

Skills

Audits (Supplier)

cGMP Knowledge

Regulatory Compliance

Audit Planning

Documentation Skills

Cross-functional Collaboration

Education

B.Pharm / M.Pharm / M.Sc

Tools

SAP ERP

Job description

Zentiva Poland seeks a Sr. Executive - Quality Compliance (Supplier Quality Assurance) to lead QA activities across the supplier network, ensuring third‑party suppliers meet GMP, regulatory requirements, and company standards in Ankleshwar.

The role oversees supplier qualification, audits, CAPAs, documentation, and collaboration with procurement, R&D, manufacturing, and regulatory affairs to drive risk‑based improvements across the pharmaceutical supply chain.