Associate Director, CQV Workstream
About the 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.
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.
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.
Qualifications
- Experience supporting biotechnology or pharmaceutical manufacturing facility startup.
- Experience with integrated commissioning and qualification delivery models.
- Project management or validation-related certification.
Skills
- Bring‑it‑on! team player attitude with an unshakable positive outlook.
- Outstanding written and verbal communication skills, conveying clarity and confidence.
- Exceptional multitasking abilities and unparalleled attention to detail.
- Master relationship‑builder, able to connect with team members, clients, vendors, and suppliers.
Benefits
- Health, dental, and vision insurance.
- 401(k) matching.
- Paid time off.
- Opportunities for career growth and development.
- Supportive and inclusive work environment.
Pay
Competitive compensation package including base salary, performance‑based bonuses, and an annual salary range of $147,200 – $184,000, depending on experience and qualifications.