Pharma CQV Program Manager

MMR Consulting; Greenville (SC); On-site; USD 120,000 - 180,000; Full time

Job summary

MMR Consulting is seeking a CQV Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects. You will oversee cross‑functional CQV execution across GMP facilities, utilities, equipment, automation, and processes while ensuring FDA and global regulatory compliance.

Travel to client sites throughout Raleigh, NC, will be required. The ideal candidate has 8+ years in pharma/biotech, 5+ years CQV PM experience in GMP environments, and

Qualifications

• Minimum 8+ years of experience in pharmaceutical, biotech, or life sciences industries.
• Minimum 5 of direct CQV project management experience within GMP‑regulated manufacturing environments.
• Experience authoring and reviewing validation lifecycle documentation.
• Strong experience leading cross‑functional teams and managing multiple project workstreams.

Responsibilities

• Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
• Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
• Coordinate commissioning and qualification activities for upstream/downstream bioprocess equipment, clean utilities, and fill-finish processes.
• Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
• Oversee execution of FAT/SAT, IQ/OQ/PQ protocols; Validation documentation; Deviations and CAPAs; Change controls.
• Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support milestones.
• Manage third-party CQV consultants, contractors, and vendors.
• Provide risk assessments and mitigation strategies to maintain timelines and compliance.
• Support startup, operational readiness, and technology transfer activities.
• Present project status updates and KPI reporting to senior leadership.

Skills

Leadership

Cross-functional collaboration

Project management

Regulatory compliance

GMP knowledge

Education

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline

Tools

Kneat

DeltaV

MES

SCADA

TrackWise

Veeva

Job description

MMR Consulting is seeking a CQV Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects. You will oversee cross‑functional CQV execution across GMP facilities, utilities, equipment, automation, and processes while ensuring FDA and global regulatory compliance.

Travel to client sites throughout Raleigh, NC, will be required. The ideal candidate has 8+ years in pharma/biotech, 5+ years CQV PM experience in GMP environments, and