CQV Project Lead

PSC Biotech; Richmond (VA); On-site; USD 83,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k)

PTO & Holidays

Education assistance

Pet insurance

Fitness discounts

Financial perks

Job summary

PSC Biotech in Richmond, VA is seeking an experienced CQV Project Lead to drive planning, coordination, and execution of commissioning, qualification, and validation activities for advanced biologics projects. The CQV Project Lead will mobilize CQV teams, manage schedules, and coordinate with Engineering, Quality, and Operations to meet regulatory expectations.

The role requires GMP/regulatory know-how, strong project management, and collaboration with cross-functional partners to deliver on

Qualifications

• CQV project leadership experience in pharma/biotech.
• Strong GMP/Regulatory knowledge and documentation.
• Proven ability to manage cross-functional teams and schedules.

Responsibilities

• Lead and oversee CQV activities from initiation to closeout, ensuring alignment with objectives, timelines, and regulatory requirements.
• Ensure successful mobilization, onboarding, and coordination of CQV 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 meet plans and quality standards.
• Coordinate CQV activities across Engineering, Manufacturing, Quality Assurance, Validation, and Operations.
• 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 CQV 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 CQV project execution and project management.

Skills

CQV Project Lead

Project management

GMP compliance

Cross-functional coordination

Microsoft Project

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Microsoft Project

Smartsheet

Primavera P6

Job description

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.

The Experience

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.

Your Role

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

This is a full role based in Richmond, VA, with an anticipated start of late October.

• 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.
  

Requirements

• 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 organizational, leadership, communication, and stakeholder management skills.
  
• Experience managing multiple project priorities, vendors, and contractors in a fast-paced project environment.
  
• Proficiency with project scheduling and planning tools such as Microsoft Project, Smartsheet, Primavera P6, or equivalent.
  

Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts
  

In accordance with Virginia's laws on pay transparency, the hourly rate for this role is set between $60 - $80. The pay offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.