Job Description
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 Mid-January 2027.

• 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.

Benefits

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.

#LI-RW1