Director - Quality - Injectable Manufacturing

Director - Quality - Injectable Manufacturing - International Assignment

Job Summary:

A globally operating pharmaceutical manufacturing organization is seeking a senior Quality leader to head Quality Assurance, Quality Control, and Microbiology functions at its injectable formulation manufacturing facility in a CIS country. This leadership role is critical in ensuring robust quality systems, regulatory compliance, and operational excellence across sterile manufacturing operations, while supporting global regulatory expectations.

- Provide end-to-end leadership for Quality Assurance and Quality Control operations within an injectable manufacturing facility.

- Oversee the Microbiology function, ensuring compliance with sterile manufacturing requirements and contamination control strategies.

- Ensure full compliance with GMP, data integrity principles, and global regulatory standards applicable to injectable products.

- Act as the primary quality representative for manufacturing operations, audits, inspections, and internal quality reviews.

- Support and coordinate with Regulatory Affairs teams on regulatory submissions, responses, and inspection readiness activities.

- Drive continuous improvement initiatives across quality systems, SOPs, investigations, CAPAs, and risk management processes.

- Lead, mentor, and develop cross-functional quality teams to build a strong quality culture across the organization.

Candidate Profile:

- 15+ years of experience in Quality functions within the pharmaceutical industry, with at least 10 years of dedicated experience in injectable or sterile manufacturing facilities.

- Strong hands-on exposure to sterile manufacturing quality systems, audits, and regulatory inspections.

- Proven leadership capability in managing large, cross-functional QA/QC and Microbiology teams.

- Prior experience working with global regulatory agencies and international quality standards is highly preferred.