Overview:

A leading, innovative biopharmaceutical organization is seeking a highly experienced Quality Control (QC) Director to lead analytical, microbial, stability, and reference standard operations within a GMP-compliant facility. This position will establish and optimize QC processes, analytical methods, and laboratory systems, ensuring alignment with strategic business goals and regulatory requirements.

Key Responsibilities:

Set strategic direction for QC laboratory operations, including budget planning, resource allocation, and facility management.

Oversee development, validation, and optimization of analytical methods for complex molecules in compliance with cGMP standards.

Lead technical staff in product testing, quality system management, and regulatory compliance.

Prepare and review technical reports, validation protocols, SOPs, and related documentation.

Manage timelines and budgets for internal projects and external service contracts.

Represent QC during regulatory, third-party, and client audits.

Recruit, train, and develop QC team members.

Collaborate cross-functionally to ensure projects meet business and compliance objectives.

Requirements:

Master’s degree in a scientific discipline (Doctorate preferred).

10+ years’ experience in a GxP pharmaceutical, biotech, or contract manufacturing/research organization.

5+ years’ leadership experience directing a QC laboratory in a cGMP facility.

In-depth knowledge of GMP/GDP regulations, ICH/FDA guidelines, and quality system requirements.

Strong technical writing, documentation, and compliance skills.

Proven people leadership and budget management capabilities.

Proficiency in Microsoft Word and Excel.

Preferred:

Experience with GLP/GCP compliance.

Demonstrated ability to manage complex, multi-disciplinary projects.