Global Quality Leader, cGMP & QMS Strategy — Hybrid

TalentAlly; Cambridge (MA); Híbrido; USD 281.000 - 397.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical, Dental, Vision, Life ins.

Tuition reimbursement

Employee stock purchase plan

Paid vacation and holidays

Resumo da vaga

Biogen is seeking a Head of Corporate Quality to lead its Global Quality Management System across US and international sites, including GMP and ICH conformance. You will drive risk assessment, policy development, vendor oversight, and GxP training, coordinating with R&D Compliance and senior regulatory bodies.

The role combines strategic leadership with hands-on management of audits, CAPAs, and continued compliance across biologics, gene therapy, devices, and digital products.

Qualificações

• Bachelor's degree in a related field; minimum 15 years of leadership in pharma.
• Minimum 10 years in Director+ level Quality/Regulatory leadership in a highly regulated environment.
• Experience with FDA/EMEA and multiple other regulatory authorities.
• Experience with clinical and commercial products across large and small molecules, devices, and combination products.
• ASQ or other auditing certification is beneficial; deep knowledge of US/International cGxPs, ISO, ICH, and device regulations.

Responsabilidades

• Lead integrated quality systems and policies across Biogen sites and PO&T locations.
• Oversee regulatory audits, risk management, and QMS improvements.
• Prepare semi-annual executive updates on QMS state and regulatory risks.
• chair Global Management Review and drive major quality initiatives within budget and schedule.

Conhecimentos

Leadership

Regulatory knowledge

cGMP knowledge

Auditing

Quality systems

Stakeholder management

Formação

Bachelor's degree in related field

Ferramentas

GxP IT systems

Descrição da vaga

Biogen is seeking a Head of Corporate Quality to lead its Global Quality Management System across US and international sites, including GMP and ICH conformance. You will drive risk assessment, policy development, vendor oversight, and GxP training, coordinating with R&D Compliance and senior regulatory bodies.

The role combines strategic leadership with hands-on management of audits, CAPAs, and continued compliance across biologics, gene therapy, devices, and digital products.