DescriptionYour 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.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $147,200 - $184,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
