CQV Workstream Lead (Associate Director)

avidbio; Tustin (CA); On-site; USD 147,000 - 184,000; Full time

Benefits offered by this job

Health, dental & vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking an Associate Director, CQV Workstream to lead commissioning, qualification, and validation efforts across projects. You will define strategy, drive readiness, and coordinate Quality, Validation, Engineering, Automation, Manufacturing, and external partners to ensure compliant delivery.

The role requires 10+ years in CQV/validation in regulated environments, with strong leadership, risk management, and documentation skills.

Qualifications

• Bachelor’s degree in engineering, life sciences, quality, or related field.
• 10+ years of commissioning, qualification, validation, quality, engineering, or capital-project delivery in a regulated environment.
• Demonstrated ownership of complex cross-functional CQV or validation initiatives.
• Working knowledge of GxP requirements, risk-based validation, documentation, and operational readiness.

Responsibilities

• Own the integrated CQV workstream strategy, plan, milestones, dependencies, risks, and deliverables through operational handover.
• Align commissioning, qualification, validation, and startup activities with project sequencing and business-readiness requirements.
• Coordinate Quality, Validation, Engineering, Automation, Manufacturing, vendors, and contractors to support compliant execution.
• Monitor workstream scope, schedule, cost, quality, documentation, and readiness, escalating material issues with clear options and recommendations.
• Provide oversight of CQV deliverables, acceptance criteria, issue resolution, and turnover documentation.
• Lead readiness planning for systems, procedures, training, documentation, and transition to the operating organization.
• Maintain workstream governance, decision records, risk documentation, and concise stakeholder reporting.
• Support inspection-ready execution and successful transition of qualified systems and processes to operations.

Skills

Leadership

Project coordination

Communication

Risk management

Education

Bachelor’s degree in engineering, life sciences, quality, or related field

Job description

Avid Bioservices in California is seeking an Associate Director, CQV Workstream to lead commissioning, qualification, and validation efforts across projects. You will define strategy, drive readiness, and coordinate Quality, Validation, Engineering, Automation, Manufacturing, and external partners to ensure compliant delivery.

The role requires 10+ years in CQV/validation in regulated environments, with strong leadership, risk management, and documentation skills.