Manager Quality CQV (Pharmaceutical Validation)

Location: Irvine, California, United States; onsite role

Salary: $125,000–$135,000 per year

Company

hirify.global is a pharmaceutical CDMO that develops and manufactures APIs and finished dosage forms across a global network of sites.

What you will do

• Own the site validation strategy, rationale, approach, and Validation Master Plan.
• Oversee facility, utility, equipment, sterilization, aseptic process, manufacturing process, cleaning, analytical method, and computer system validation.
• Coordinate validation schedules, resources, activities, and deliverables with Project Management, Engineering, MS&T, and Operations.
• Manage process validation activities for existing products and new product introductions, including continued process verification.
• Lead the QA Sterilization Validation group and manage consultants and contractors.
• Support GMP training, change management, deviations, investigations, audits, and regulatory inspections.

Requirements

• Bachelor’s degree in engineering, science, or a related technical discipline.
• 6–10 years of experience in an FDA- or GMP-regulated environment.
• Experience with commissioning, qualification, and validation activities under a Site Validation Master Plan.
• Working knowledge of cGMP regulations, cleanroom manufacturing environments, validation documentation, SOPs, protocols, and reports.
• Experience managing direct reports and cross-functional teams, with the ability to delegate, influence change, and manage multiple projects.
• Strong written and verbal communication, technical writing, data analysis, decision-making, and interpersonal skills.

Nice to have

• 6–10 years of experience in the pharmaceutical industry.
• 3–5 years of supervisory experience managing direct reports or teams of 5–10 people.
• Experience in aseptic manufacturing and cleanroom environments.

Culture & Benefits

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