CQV Site Leader: Validation & Compliance

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

Benefits offered by this job

Medical, Dental, Vision

FSA/HSA Options

401K

Job summary

Siegfried Irvine requires an experienced CQV leader to oversee commissioning, qualification, and validation for drugs, devices, and manufacturing processes. You will manage the Site Validation Master Plan, supervise validation activities, and coordinate with PM, Engineering, MS&T, and Operations for new product introductions.

Ideal candidates have GMP/cGMP experience, strong leadership, and excellent communication skills to support regulatory inspections and client audits.

Qualifications

• Experience with CQV activities within a Site Validation Master Plan.

Responsibilities

• Oversee site validation master plan development, rationale, and approach.
• Coordinate qualification activities and document approvals across facility, utilities, equipment, sterilization, aseptic validation, PPQ, cleaning, analytical methods, computer validation, and environmental monitoring.
• Manage QA Sterilization Validation group and oversee consultants.
• Represent CQV program during regulatory inspections and client audits.

Skills

CQV oversight

GMP experience

Leadership

Cross-functional collaboration

Regulatory inspections

Documentation review

Validation data analysis

Project coordination

Auditing skills

Education

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

Job description

Siegfried Irvine requires an experienced CQV leader to oversee commissioning, qualification, and validation for drugs, devices, and manufacturing processes. You will manage the Site Validation Master Plan, supervise validation activities, and coordinate with PM, Engineering, MS&T, and Operations for new product introductions.

Ideal candidates have GMP/cGMP experience, strong leadership, and excellent communication skills to support regulatory inspections and client audits.