Associate Director, CQV Workstream
Avid Bioservices
Summary
The Associate Director, CQV Workstream provides owner-side leadership for commissioning, qualification, and validation scope within identified projects. The role establishes and integrates the CQV strategy, execution plan, dependencies, documentation, and readiness requirements across project and operating teams. The position is accountable for workstream scope, schedule, cost, risk, quality, and handover while coordinating Quality, Validation, Engineering, Automation, Manufacturing, and external partners. The role operates with substantial day-to-day independence and escalates material commitments or changes through the appropriate project governance channels.
Job description
Your Role
The Associate Director, CQV Workstream provides owner-side leadership for commissioning, qualification, and validation scope within identified projects. The role establishes and integrates the CQV strategy, execution plan, dependencies, documentation, and readiness requirements across project and operating teams. The position is accountable for workstream scope, schedule, cost, risk, quality, and handover while coordinating Quality, Validation, Engineering, Automation, Manufacturing, and external partners. The role operates with substantial day-to-day independence and escalates material commitments or changes through the appropriate project governance channels.
Key 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.
Minimum Qualifications
- Bachelor’s degree in engineering, life sciences, quality, or a related field, or equivalent relevant experience.
- 10 or more years of relevant experience in 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.
Preferred Qualifications
- Experience supporting biotechnology or pharmaceutical manufacturing facility startup.
- Experience with integrated commissioning and qualification delivery models.
- Project management or validation-related certification.
Position Type/Expected Hours of Work
This role is a full-time onsite position. Schedule flexibility may be required to support project milestones, commissioning, startup, and operational-readiness activities. The employee must also have the ability to work overtime and/or weekends when necessary.
Requirements
- Bachelor’s degree in engineering, life sciences, quality, or a related field, or equivalent relevant experience
- 10 or more years of relevant experience in 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
- Experience supporting biotechnology or pharmaceutical manufacturing facility startup
- Experience with integrated commissioning and qualification delivery models
- Project management or validation-related certification
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
- Performance-based bonuses
- Career growth opportunities
Company overview
Avid Bioservices is a leading contract development and manufacturing organization (CDMO) specializing in biologics derived from mammalian cell culture systems. Founded in 1993 and headquartered in Tustin, California, the company has over 30 years of experience in biologics manufacturing. Avid provides comprehensive process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. Their expertise spans from early-stage process development to full-scale commercial manufacturing, including cell line development, upstream and downstream optimization, analytical methods development, and regulatory submissions support. The company has produced more than 250 commercial batches and has five commercial products marketed in over 90 countries. With state-of-the-art facilities and a flawless quality track record maintained for over a decade, Avid Bioservices focuses on transforming the CDMO experience through personalized processes, unrivaled expertise, and exceptional quality standards. The company was recently acquired by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion transaction, positioning it for continued growth in the biologics manufacturing sector.