CQV Quality Leader: Validation Strategy & Compliance

Siegfried Group; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending & HSA Options

Life Insurance

Short & Long Term Disability

Pet Insurance

Generous PTO, Sick & Holiday Time Off

401K

Job summary

Siegfried Irvine seeks an experienced CQV leader to oversee commissioning, qualification, and validation for drug products, devices, and processes. You will manage the Site Validation Master Plan, coordinate cross‑functional teams, and drive GMP compliance across the site.

Ideal candidates bring extensive FDA/GMP experience, aseptic manufacturing familiarity, and strong leadership for a high‑impact CQV program in a global pharma environment.

Qualifications

• Bachelor’s Degree in engineering, science or related technical discipline.
• 6–10 years of experience in an FDA or GMP‑regulated environment.
• 6–10 years of pharmaceutical industry experience preferred.
• 3–5 years of supervisory experience managing direct reports or teams.
• Experience in aseptic manufacturing/cleanrooms preferred.

Responsibilities

• Oversee the site validation strategy, rationale and approach.
• Manage the Site Validation Master Plan and qualification documents.
• Coordinate qualification activities: facility, utility, equipment, sterilization, aseptic, PPQ, cleaning, analytical method validation, CSV, environmental monitoring.
• Coordinate validation life cycle for existing products and new product introductions.
• Collaborate with Project Management, Engineering, MS&T and Operations for design, delivery, commissioning and qualification.
• Represent CQV in regulatory inspections and client audits.

Skills

CQV leadership

Validation management

GMP compliance

Project coordination

People management

cGMP knowledge

Technical writing

Regulatory inspections

Education

Bachelor’s degree in engineering/science

Job description

Siegfried Irvine seeks an experienced CQV leader to oversee commissioning, qualification, and validation for drug products, devices, and processes. You will manage the Site Validation Master Plan, coordinate cross‑functional teams, and drive GMP compliance across the site.

Ideal candidates bring extensive FDA/GMP experience, aseptic manufacturing familiarity, and strong leadership for a high‑impact CQV program in a global pharma environment.