CQV Project Lead

Richmond, United States | Posted on 09/02/2026

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech, it’s about more than just a job—it’s about your career and your future.

We are seeking an experienced CQV Project Lead to lead the planning, coordination, and execution of C&Q activities for advanced biologics manufacturing projects. The CQV Project Lead will be responsible for ensuring the successful mobilization of C&Q teams, managing project schedules and resource forecasts, and overseeing the delivery of C&Q activities throughout the project lifecycle. This position requires strong pharmaceutical industry experience, exceptional project management skills, and the ability to effectively coordinate cross-functional stakeholders to ensure projects are executed safely, compliantly, and on schedule

• Lead and oversee C&Q activities from project initiation through closeout, ensuring alignment with project objectives, timelines, and regulatory requirements.
• Ensure successful mobilization, onboarding, and coordination of C&Q teams to support project execution.
• Develop, maintain, and manage project schedules, resource forecasts, and staffing plans to support successful project delivery.
• Provide oversight of commissioning, qualification, and validation activities, ensuring deliverables are completed in accordance with approved plans and quality standards.
• Coordinate C&Q activities across Engineering, Manufacturing, Quality Assurance, Validation, and Operations organizations.
• Monitor project progress, identify risks and issues, and implement mitigation strategies to maintain schedule and budget commitments.
• Manage external vendors, contractors, and consulting partners supporting C&Q execution.
• Ensure documentation, protocols, reports, and turnover packages meet GMP and regulatory requirements.
• Prepare and communicate project status updates, resource requirements, risks, and milestones to clients and senior stakeholders.
• Support continuous improvement initiatives and promote best practices in C&Q project execution and project management.

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
• 8+ years of experience in CQV, Validation, Engineering, or Project Management within the pharmaceutical or biotechnology industry.
• Demonstrated experience supporting advanced biologics manufacturing facilities and operations.
• Proven experience leading CQV projects and managing cross-functional teams in GMP-regulated environments.
• Strong experience developing and managing project schedules, resource forecasts, and staffing plans.
• Experience overseeing commissioning, qualification, and validation activities, including IQ/OQ/PQ execution and validation documentation.
• Working knowledge of cGMP regulations, FDA requirements, and industry best practices related to CQV execution.
• Excellent…