QCS-CQV Project Director

2 weeks ago Be among the first 25 applicants

This range is provided by Unicon Pharma Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $80.00/hr

Direct message the job poster from Unicon Pharma Inc

Recruiter at Unicon Pharma | Quality & Compliance | Validation

Position: QCS–CQV Project Director

Location: NC (Onsite)

Start: ASAP

Duration: 6 months to start (possibility of extension based)

Hours: 40 hrs/week

*Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

*Due to client requirement, applicants must be willing and able to work on a w2 basis

Overview

We are seeking an accomplished QCS–CQV Project Director to lead the commissioning, qualification, and start-up of a large-scale biologics drug substance facility. This senior leadership role will oversee all phases of the project — from design through operational handover — ensuring delivery of complex, high-value equipment packages and facility systems that meet cGMP and regulatory requirements.

Key Responsibilities

• Direct the end-to-end delivery of a greenfield CQV project, including planning, execution, risk management, and operational readiness.
• Oversee the procurement, installation, commissioning, and qualification of equipment packages valued at $100–200M .
• Lead and inspire multidisciplinary teams of up to 60 personnel , including internal staff, contractors, and vendor partners.
• Ensure alignment between CQV activities, process engineering deliverables, and overall project timelines and budgets.
• Drive adherence to quality, safety, and compliance standards across all project phases.
• Collaborate closely with operations teams to ensure smooth transition from project delivery to commercial manufacturing, including facility acceptance and ramp-up.
• Provide executive-level reporting and stakeholder engagement to maintain alignment on scope, progress, and risk mitigation.

Qualifications

• 15+ years of experience in process engineering, CQV, or project management within the biologics drug substance space.
• Candidates with 10+ years and an exceptional track record will also be considered.
• Proven leadership in delivering full lifecycle projects from concept through operational start-up.
• Demonstrated success managing complex equipment packages in the $100–200M range.
• Experience overseeing large, diverse teams (up to 60 people) on major capital projects.
• Greenfield project experience is essential.
• Operational leadership experience, particularly in accepting facilities from a project team into GMP operations, is highly beneficial.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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