Global CQV Leader — GMP Validation & QA Excellence

Initial Therapeutics, Inc.; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

PTO

Life Insurance

Job summary

Siegfried Irvine site seeks an experienced CQV Program lead to oversee all commissioning, qualification, and validation activities for drug products, medical devices, and manufacturing processes. You will manage the Site Validation Master Plan, coordinate cross-functional teams, and liaise with QA and operations to ensure compliant, timely delivery.

The role reports to site leadership and requires strong GMP knowledge, leadership, and communication skills to support regulatory inspections and

Qualifications

• Experience with commissioning, qualification, and validation activities within a Site Validation Master Plan.
• Experience in GMP-regulated environments and cleanroom manufacturing preferred.
• Ability to lead cross-functional teams and manage direct reports.

Responsibilities

• Own and manage the site validation strategy, master plan, and qualification activities.
• Oversee qualification of facility, utilities, equipment, sterilization, aseptic processes, and analytical methods.
• Coordinate validation life cycle for existing products and new product introductions.
• Lead project coordination with PM, Engineering, MS&T, and Operations for CQV deliverables.
• Manage QA Sterilization Validation group and external consultants.
• Represent CQV program in regulatory inspections and client audits.

Skills

CQV oversight

Validation strategy

Leadership

Project coordination

GMP/cGMP knowledge

Technical writing

Communication skills

Cross-functional collaboration

Education

Bachelor’s Degree in engineering, science, or related technical discipline

Tools

GMP Documentation Systems

Job description

Siegfried Irvine site seeks an experienced CQV Program lead to oversee all commissioning, qualification, and validation activities for drug products, medical devices, and manufacturing processes. You will manage the Site Validation Master Plan, coordinate cross-functional teams, and liaise with QA and operations to ensure compliant, timely delivery.

The role reports to site leadership and requires strong GMP knowledge, leadership, and communication skills to support regulatory inspections and