QC Systems Owner (pharma)

Qualifications & Skills :

• Bachelor’s Degree in Life Sciences, Chemistry, Biotechnology, or related field
• 7+ years of experience managing laboratory systems and operations within a GMP environment
• Deep understanding of laboratory automation, data integrity, validation protocols, and regulatory compliance
• Experience with LIMS, ELN, and other laboratory information systems
• Strong knowledge of GMP, FDA, EMA, ICH, and ISO standards
• Proven ability to lead cross-functional teams and manage stakeholder expectations
• Excellent project management, organizational, and communication skills
• Familiarity with change control systems, risk management, and continuous improvement methodologies

Pluses :

Job Description :

We are seeking an experienced and detail-oriented professional to serve as the System Owner for the Quality Control (QC) laboratory at a large-scale, greenfield biologics manufacturing facility specializing in large molecule drugs. This role is critical in establishing and maintaining the operational readiness of the QC laboratory, ensuring compliance with regulatory standards, and supporting the seamless integration of laboratory systems and processes within the new facility.

Core Responsibilities