Quality Compliance Lead, Regulatory Affairs

Zentiva Poland; Hinoba-an; On-site; PHP 796,000 - 1,194,000; Full time

Job summary

Zentiva Poland seeks an Assistant Manager I, Quality Compliance to lead QA activities across GxP compliance, regulatory affairs, and audits. The role requires deep GMP knowledge and extensive experience in investigations, CAPAs, and cross‑functional collaboration.

The position focuses on implementing global quality standards at the Ankleshwar site, coordinating regulatory dossiers and ensuring product quality aligns with health authority expectations.

Qualifications

• Knowledge of GMP and regulatory requirements.
• Experience with quality management systems and regulatory submissions.
• Ability to manage investigations, CAPAs and cross‑functional interfaces.
• Global/regulatory awareness and ability to coordinate with multiple stakeholders.

Responsibilities

• Implement Zentiva quality policies and guidelines.
• Review and approve GxP documents (QM, SOPs, validation reports, MBRs, specifications).
• Coordinate regulatory submissions and responses to authorities.
• Lead internal audits and supplier audits; manage self‑inspection program.
• Prepare and review CMC documentation for global Regulatory Affairs.

Skills

Quality compliance

Regulatory affairs

GxP knowledge

CAPA management

Analytical testing

Method validation

Process validation

Audit preparation

SOP development

Education

Postgraduate in Pharmacy

Job description

Zentiva Poland seeks an Assistant Manager I, Quality Compliance to lead QA activities across GxP compliance, regulatory affairs, and audits. The role requires deep GMP knowledge and extensive experience in investigations, CAPAs, and cross‑functional collaboration.

The position focuses on implementing global quality standards at the Ankleshwar site, coordinating regulatory dossiers and ensuring product quality aligns with health authority expectations.