Quality Assurance Manager - Construction

NOTE: No 3rd Party companies.....

CONSTRUCTION QUALITY ASSURANCE MANAGER -

EPC - PHARMACEUTICAL/LIFE SCIENCES/BIOTECH

We are seeking an experienced Construction Quality Manager for leading EPC to oversee construction quality performance for a major, $500M+ greenfield pharmaceutical manufacturing project . In this leadership role, you will manage EPCM contractors, suppliers, and CQV partners to deliver a world-class facility from design through startup.

Key Responsibilities

• Quality Governance: Develop the Project Quality Management Plan (QMP), establish KPIs, and lead project quality reviews and risk assessments.
• Construction & Supplier Oversight: Manage owner-side quality surveillance across all disciplines (civil, mechanical, electrical, automation). Oversee supplier quality programs for critical GMP infrastructure and process equipment.
• Design & Engineering Quality: Review design quality processes, manage engineering deviations, and ensure design updates align with project standards.
• CQV & GMP Compliance: Coordinate with Commissioning, Qualification, and Validation (CQV) teams. Ensure all documentation supports FDA, EMA, and MHRA regulatory inspections.
• Audit & Team Leadership: Execute project audit programs, manage CAPAs, and foster a "right-first-time" quality culture across multidisciplinary contractor teams.

Required Qualifications

• Education: Bachelor’s degree in Engineering, Construction Management, Life Sciences, or a related technical field.
• Experience:
• 15+ years of capital project quality management experience.
• 10+ years within pharmaceutical, biotech, or GMP-regulated industries.
• Proven track record on mega-projects exceeding $500M TIC .
• Complete project lifecycle experience (Design, Construction, CQV, Handover).
• Skills: Deep knowledge of GMP requirements and pharmaceutical facility delivery.

Preferred Qualifications

• Certifications: ASQ CMQ/OE, CQE, PE, or PMP.
• Project Expertise: Experience with cleanrooms, sterile processing, biologics, or cell and gene therapy facilities.
• Previous experience as an Owner’s Representative or managing EPCM oversight.