Global VP of Quality & Regulatory Readiness

CellCentric; Boston (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

CellCentric is seeking a Vice President, Quality Assurance to lead our global QA function through Phase 3 development, NDA/MAA registration and commercial readiness. You will own the QMS, GxP oversight, inspection readiness and external partner quality within a lean outsourced biotech environment.

The role requires 15+ years in biotech/pharma QA, Phase 3 leadership, and strong collaboration with Regulatory Affairs and Technical Operations to ensure submission readiness and health-authority

Qualifications

• Bachelor’s degree in a scientific, engineering, pharmaceutical or related discipline is required or preferred.
• 15+ years of progressive Quality Assurance experience in biotechnology or pharmaceuticals.
• Experience leading Quality through Phase 3 and NDA registration, including submissions and FDA PAI preparation.

Responsibilities

• Lead the global Quality strategy, QMS and governance framework for late-stage development and commercialisation.
• Drive Quality readiness for NDA/MAA registration, GMP systems, documentation and inspection readiness.
• Partner with Regulatory Affairs and Technical Operations on submissions and health-authority responses.
• Oversee FDA Pre-Approval Inspections and other health-authority inspections, including mock inspections and remediation.
• Manage deviations, investigations, CAPAs, change control, audits, data integrity, vendor qualification and management review.
• Oversee CDMOs, laboratories, CROs and other GxP partners within an outsourced model.
• Ensure Quality readiness for validation, batch disposition, complaints, recalls and lifecycle management.
• Provide risk-based Quality oversight of clinical development and GCP activities.
• Build scalable Quality capabilities, resources and processes for a growing company.
• Lead interactions with FDA and other regulators, including inspections and responses.
• Develop and lead the Quality organisation with clear objectives and metrics.

Skills

Quality leadership

FDA cGMP knowledge

Phase 3 experience

Regulatory inspections

GxP oversight

Cross-functional collaboration

Supplier quality management

Education

Bachelor’s degree in a scientific, engineering, pharmaceutical or related discipline

Advanced degree preferred

Job description

CellCentric is seeking a Vice President, Quality Assurance to lead our global QA function through Phase 3 development, NDA/MAA registration and commercial readiness. You will own the QMS, GxP oversight, inspection readiness and external partner quality within a lean outsourced biotech environment.

The role requires 15+ years in biotech/pharma QA, Phase 3 leadership, and strong collaboration with Regulatory Affairs and Technical Operations to ensure submission readiness and health-authority