VP of Quality Operations – Biopharma & Devices (Onsite)

LHH; North Carolina; On-site; USD 350,000 - 600,000; Full time

Job summary

LHH invites applications for a Vice President, Quality Operations to lead Quality Assurance and Quality Control for pharmaceutical and combination product manufacturing at a Research Triangle Park site. The role focuses on regulatory compliance, inspection readiness, and continuous improvement across drug product and medical device operations.

The executive will drive strategic quality initiatives, collaborate with cross-functional teams, and ensure robust quality systems, process validation,

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 15+ years of progressive quality leadership in pharma/biotech/device/manufacturing.
• 10+ years leading QA and QC organizations.
• Deep knowledge of FDA, EU GMP regs and inspections.
• Proven ability to build high-performing teams in a regulated environment.

Responsibilities

• Oversee Quality Operations across pharmaceutical and combination product manufacturing.
• Ensure compliance with FDA, EMA, and GMP/GDP regulations.
• Lead QA and QC organizations and drive inspection readiness.
• Guide regulatory authority interactions and inspections.
• Support facility start-up, validation, qualification, and commercialization activities.
• Review deviations, CAPAs, change controls, validation protocols, and batch disposition.

Skills

Leadership

Regulatory knowledge

Strategic thinking

Inspection readiness

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Advanced degree (MS, MBA, PharmD, or PhD)

Job description

LHH invites applications for a Vice President, Quality Operations to lead Quality Assurance and Quality Control for pharmaceutical and combination product manufacturing at a Research Triangle Park site. The role focuses on regulatory compliance, inspection readiness, and continuous improvement across drug product and medical device operations.

The executive will drive strategic quality initiatives, collaborate with cross-functional teams, and ensure robust quality systems, process validation,