CQV Project Manager

Quanta Consultancy Services Ltd; North Carolina; On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a CQV Project Manager to lead a transformative biomanufacturing project on the East Coast. This role offers the opportunity to develop and implement a comprehensive CQV strategy for a $1 billion greenfield project, ensuring compliance with regulatory standards and operational excellence. You'll build and lead a high-performing team, driving project execution while collaborating closely with engineering and manufacturing teams. If you're passionate about making a difference in the biotechnology field and have a strong background in CQV project management, this is your chance to contribute to a mission that aims to improve lives affected by disease.

Qualifications

• Extensive experience in CQV project management in biopharmaceuticals.
• Proven leadership in large-scale greenfield drug substance projects.

Responsibilities

• Develop and implement CQV strategy for a $1 billion project.
• Lead CQV lifecycle from design to operational readiness.
• Manage stakeholder communication and report on CQV progress.

Skills

CQV Project Management

Regulatory Compliance (FDA, EMA, GMP)

Stakeholder Management

Leadership

Risk Management

Education

Bachelor's Degree in Engineering or Life Sciences

Project Management Certification

Tools

Kneat

Job description

CQV Project Manager - RTP, North Carolina - 12 Months Contract

Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of CQV Project Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based on the East Coast.

Essential duties and responsibilities for this role include, but are not limited to, the following:

1. Develop and implement the CQV strategy for a $1 billion greenfield project, ensuring compliance with regulatory and operational requirements.
2. Lead the full CQV lifecycle, from early design phases through execution, qualification, and operational readiness.
3. Define the CQV strategy, including risk-based approaches, qualification requirements, and validation master plans.
4. Build and lead a high-performing CQV team, overseeing staffing, resource allocation, and performance management.
5. Utilize Kneat for digital validation and documentation management.
6. Ensure alignment with industry regulations, company policies, and best practices in commissioning and validation.
7. Collaborate closely with engineering, construction, and manufacturing teams to ensure smooth integration of CQV activities.
8. Drive project execution, maintaining timelines, budgets, and quality expectations.
9. Manage stakeholder communication, reporting CQV progress, risks, and mitigation strategies to senior leadership.

Desirable Experience:

1. Extensive experience in CQV project management within the biopharmaceutical or life sciences industry.
2. Proven experience leading CQV efforts for large-scale greenfield drug substance projects ($500M+).
3. End-to-end project delivery experience, from design through operational handover.
4. Expertise in defining and executing CQV strategies for complex manufacturing facilities.
5. Strong leadership experience, including building and managing CQV teams.
6. Kneat expertise is required.
7. Deep understanding of regulatory compliance (FDA, EMA, GMP) and industry standards.
8. Excellent stakeholder management skills with the ability to interface across engineering, quality, and operations teams.

If this role is of interest, please apply now.