Lead CQV & Validation Strategy Manager

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

Job summary

Siegfried Irvine is seeking a seasoned site CQV Lead to oversee commissioning, qualification, and validation activities for drugs, devices, and manufacturing processes. You will manage the Site Validation Master Plan, coordinate with project teams, and ensure compliance with GMP standards and regulatory expectations.

The role requires extensive CQV experience, leadership of teams, and strong analytical and communication skills to drive successful audits and client interactions.

Qualifications

• Experience with CQV activities and processes within a Site Validation Master Plan.
• Ability to delegate responsibilities and coordinate across functions.
• Experience leading cross-functional teams and managing direct reports.
• Ability to interpret validation data and determine acceptance criteria.
• Leadership and strong communication for regulatory inspections and audits.

Responsibilities

• Own the site validation strategy, rationale, and approach.
• Manage Site Validation Master Plan and oversee qualification activities and documents.
• Lead Sterilization Validation, Aseptic Process Simulation/Media Fill Validation, and PPQ validation.
• Oversee Cleaning Validation, Analytical Method Validation, and Computer System Validation.
• Coordinate Environmental Monitoring Program and validation life cycle for new/existing products.
• Schedule/resource management with PM, Eng, MS&T, and Operations for CI/installation.
• Oversee QA Sterilization Validation group and liaise with consultants as needed.
• Represent CQV in regulatory inspections and client audits.

Skills

CQV management

GMP knowledge

Leadership

Cross-functional coordination

Analytical thinking

Project management

Communication skills

Education

Bachelor's degree in engineering or science

Job description

Siegfried Irvine is seeking a seasoned site CQV Lead to oversee commissioning, qualification, and validation activities for drugs, devices, and manufacturing processes. You will manage the Site Validation Master Plan, coordinate with project teams, and ensure compliance with GMP standards and regulatory expectations.

The role requires extensive CQV experience, leadership of teams, and strong analytical and communication skills to drive successful audits and client interactions.