Manager Quality CQV (Pharmaceutical Validation)

Location: Irvine, California, United States

Salary: $125,000–$135,000 annually

Company

Global pharmaceutical CDMO supporting the development, scale-up, and manufacturing of APIs and finished dosage forms across a network of sites.

What you will do

• Own and manage the site validation strategy, rationale, approach, and Validation Master Plan.
• Oversee facility, utility, equipment, sterilization, aseptic process simulation, manufacturing process, cleaning, analytical method, and computer system validation.
• Coordinate CQV schedules, resources, deliverables, and cross-functional activities for new product introductions and existing validated processes.
• Manage the QA Sterilization Validation group, validation consultants, contractors, and site GMP training activities.
• Support change management, deviation investigations, root cause analysis, impact assessments, and corrective and preventive actions.
• Represent the site CQV program during regulatory inspections and client audits.

Requirements

• Bachelor’s degree in engineering, science, or a related technical discipline.
• 6–10 years of experience in an FDA- or GMP-regulated environment and preferably in the pharmaceutical industry.
• Experience with commissioning, qualification, validation, GMP compliance, cGMP requirements, and cleanroom manufacturing environments.
• 3–5 years of supervisory experience managing direct reports or teams of 5–10 people is preferred.
• Ability to analyze validation data, approve GMP documentation, coordinate cross-functional teams, and manage multiple projects.
• Strong leadership, communication, technical writing, decision-making, and interpersonal skills.

Nice to have

• Experience working in aseptic manufacturing and cleanrooms.
• Experience managing direct reports or cross-functional teams.

Culture & Benefits

• Medical, dental, and vision insurance.
• Flexible Spending Account and HSA options.
• Life insurance and short- and long-term disability coverage.
• Pet insurance.
• Generous paid time off, sick leave, and holiday time off.
• 401(k) plan.