Manager Quality CQV

Siegfried seeks a Manager of Quality CQV to oversee commissioning, qualification, and validation processes for drug products, medical devices, and manufacturing at their Irvine facility. The role involves managing validation strategy, coordinating cross-functional teams, and ensuring GMP compliance.

Responsibilities

• Develop and maintain site validation strategy, master plan, and approach for all CQV processes
• Manage sterilization validation, aseptic process simulation, process validation, cleaning validation, and analytical method validation activities
• Oversee qualification protocols and documentation approval within the Site Validation Master Plan scope
• Coordinate schedules, resources, and deliverables with project management, engineering, and operations teams
• Manage QA sterilization validation group and external validation consultants; represent CQV program in regulatory inspections and audits

Requirements

• Bachelor's degree in engineering, science, or related technical discipline
• 6–10 years experience in FDA or GMP-regulated environment
• 6–10 years pharmaceutical industry experience preferred
• 3–5 years supervisory experience managing teams of 5–10 people preferred
• Expertise in CQV activities including sterilization, process validation, and analytical method validation
• Strong GMP compliance knowledge and cleanroom manufacturing familiarity
• Proven ability to analyze validation data, manage direct reports, and lead cross-functional teams

Compensation: $125,000–$135,000 base