Global VP of Quality & Compliance, Biotech

SanegeneBio; Woburn (MA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

SanegeneBio seeks an experienced Vice President, Quality to shape and lead global R&D Qx strategy across GxP domains, guiding quality governance and inspection readiness as the company advances its preclinical and clinical programs.

You will oversee QMS, CAPAs, audits, and vendor quality while partnering with cross-functional leaders to ensure regulatory readiness and data-driven decision-making across the U.S. and China sites.

Qualifications

• 15+ years of progressive quality experience in biotechnology/pharmaceuticals across GxP disciplines.
• Minimum of 5 years of people leadership and cross-regional management.
• Extensive knowledge of FDA, EMA, MHRA, NMPA, PMDA regulations and ICH guidelines.
• Proven track record hosting global Health Authority inspections and scaling a QMS.

Responsabilités

• Advise the CEO and Leadership Team on quality risks with clear, risk-based recommendations.
• Lead the China-based Quality team and align with US operations in a phase-appropriate, solutions-focused Quality organization.
• Oversee the global QMS, deviation/investigation/CAPAs, change control, audits, data integrity, and vendor qualification.
• Ensure cGMP, cGMP oversight for manufacturing, clinical supply disposition, and supplier quality across sites.
• Host and support HAI inspections and manage quality interactions with health authorities and CRO/CDMO partners.
• Drive phase-appropriate metrics, analytics, and reporting to enable proactive risk management.

Connaissances

Leadership

GxP Knowledge

Regulatory Compliance

Quality Strategy

Formation

Bachelor's or Master's in life science or related field

Ph.D. preferred

Description du poste

SanegeneBio seeks an experienced Vice President, Quality to shape and lead global R&D Qx strategy across GxP domains, guiding quality governance and inspection readiness as the company advances its preclinical and clinical programs.

You will oversee QMS, CAPAs, audits, and vendor quality while partnering with cross-functional leaders to ensure regulatory readiness and data-driven decision-making across the U.S. and China sites.