CQV Workstream Director - Biopharma Validation

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

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) matching

Job summary

Avid Bioservices in California seeks an Associate Director CQV Workstream to lead owner-side commissioning, qualification and validation across complex biopharmaceutical projects, ensuring readiness and regulatory compliance.

You will own strategy, plan, milestones, and handover, coordinating Quality, Validation, Engineering, Automation, Manufacturing, and external partners to deliver compliant systems and processes.

Qualifications

• Bachelor’s degree or equivalent in engineering, life sciences, quality, or related field.
• 10+ years of CQV/validation in a regulated environment.
• Strong ownership of cross-functional CQV initiatives.
• Working knowledge of GxP requirements and quality documentation.

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 readiness requirements.
• Coordinate Quality, Validation, Engineering, Automation, Manufacturing, vendors, and contractors to support compliant execution.
• Monitor scope, schedule, cost, quality, documentation, and readiness, escalating material issues with 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 operations.
• Maintain workstream governance, decision records, risk documentation, and stakeholder reporting.
• Support inspection-ready execution and successful transition of qualified systems to operations.

Skills

CQV leadership

Cross-functional coordination

GxP knowledge

Regulated environment

Project management

Education

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

Job description

Avid Bioservices in California seeks an Associate Director CQV Workstream to lead owner-side commissioning, qualification and validation across complex biopharmaceutical projects, ensuring readiness and regulatory compliance.

You will own strategy, plan, milestones, and handover, coordinating Quality, Validation, Engineering, Automation, Manufacturing, and external partners to deliver compliant systems and processes.