Vice President Quality Assurance

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

The Vice President, Quality Assurance leads CellCentric’s global Quality Assurance function through Phase 3 development, NDA/MAA registration and commercial readiness. The role owns the Quality Management System (QMS), GxP oversight, inspection readiness and external partner quality in a lean, outsourced biotech environment, while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.

Key Responsibilities

• Lead the global Quality strategy, QMS and governance framework supporting late-stage development, registration, approval and commercialisation.
• Lead Quality readiness for NDA/MAA registration, ensuring GMP systems, documentation and manufacturing controls are complete and inspection-ready.
• Partner with Regulatory Affairs and Technical Operations on submission readiness, CMC Quality review and health-authority responses.
• Lead FDA Pre-Approval Inspection (PAI) and other health-authority inspection readiness, including mock inspections, SME preparation and remediation.
• Oversee GxP compliance, including deviations, investigations, CAPAs, change control, audits, data integrity, training, vendor qualification and management review.
• Oversee CDMOs, laboratories, CROs and other GxP partners, including qualification, quality agreements, audits, performance and escalation.
• Ensure Quality readiness for validation, commercial batch disposition, complaints, recalls and post-approval lifecycle management.
• Provide risk-based Quality oversight of clinical development and GCP activities and resolve significant quality and compliance issues cross-functionally.
• Build scalable Quality capabilities, resources and processes for a growing late-stage biotechnology company.
• Provide senior Quality leadership in interactions with FDA and other global regulatory authorities, including inspections, responses to findings and representation of the company on GxP compliance matters.
• Build, develop and lead the Quality organisation, establishing clear objectives, performance measures and capabilities to support registration and commercialisation.
• Oversee Supplier Quality and external testing laboratories, including qualification, monitoring, quality agreements and risk-based performance management.
• Own Quality functional planning, budget and resource requirements, ensuring capabilities evolve appropriately as the organisation progresses toward approval and commercialisation.

Skills and Qualifications

• Bachelor’s degree in a scientific, engineering, pharmaceutical or related discipline; advanced degree preferred.
• 15+ years of progressive Quality Assurance experience in biotechnology or pharmaceuticals, including leadership in late-stage development and/or commercial organisations.
• Demonstrated experience leading Quality through Phase 3 and NDA registration, including submission readiness, health-authority responses and FDA PAI preparation/support.
• Strong knowledge of FDA cGMP requirements, ICH guidelines and global quality expectations; working knowledge of EMA/MHRA requirements and GCP principles.
• Experience establishing and scaling a pharmaceutical QMS, with strong GMP expertise across manufacturing, validation, batch disposition, investigations, CAPA and change control.
• Proven experience overseeing CDMOs, contract laboratories, CROs and other GxP partners in an outsourced operating model.
• Strong leadership, judgement and influencing skills, with the ability to make pragmatic, risk-based decisions across functions and geographies.
• Broad Quality experience across GMP, GCP and, where applicable, GLP and Quality Control, with demonstrated experience leading regulatory inspections and interactions with FDA and other global health authorities.

Working Behaviors (Core Expectations)

• Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
• Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
• Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
• Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
• Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.

Why Join Us?

At CellCentric, we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.