CQV Quality Lead: Validation & Compliance

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA & HSA

Life Insurance

Pet Insurance

Paid Time Off

401K

Job summary

Siegfried Irvine seeks a Site CQV Leader to oversee commissioning, qualification, and validation of facility, equipment, and processes for drug products and devices. You will drive the Site Validation Master Plan, coordinate cross-functional teams, and ensure cGMP compliance across QA, MS&T, Engineering, and Operations.

Responsibilities include managing validation life cycle, authoring and approving protocols, leading a team of validation professionals, and representing the site during

Qualifications

• Experience with commissioning, qualification, and validation activities within Site Validation Master Plan.
• Ability to delegate and coordinate with other functional areas.
• Ability to manage direct reports and cross-functional teams.
• Ability to analyze validation data to determine acceptance criteria.
• Strong leadership and communication skills in a GMP environment.

Responsibilities

• Oversee and manage CQV for new and existing drug products, devices, and processes.
• Own Site Validation Master Plan and approve qualification documents.
• Coordinate validation activities with Project Management, Engineering, MS&T, and Operations.
• Lead QA Sterilization Validation group and manage contractors as needed.
• Represent CQV program in regulatory inspections and audits.

Skills

CQV management

Leadership

Cross-functional coordination

GMP compliance

Data interpretation

Communication

Education

Bachelor's Degree in engineering/science

Tools

Validation Protocols

QA Documentation

Cleanroom knowledge

Job description

Siegfried Irvine seeks a Site CQV Leader to oversee commissioning, qualification, and validation of facility, equipment, and processes for drug products and devices. You will drive the Site Validation Master Plan, coordinate cross-functional teams, and ensure cGMP compliance across QA, MS&T, Engineering, and Operations.

Responsibilities include managing validation life cycle, authoring and approving protocols, leading a team of validation professionals, and representing the site during