Global Quality & Compliance Executive

Biogen, Inc.; Cambridge (MA); Hybrid; USD 281,000 - 397,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

15 days paid vacation and year-end休

Company holidays

Maternity and Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement up to $10,000

Job summary

Biogen, Inc. is seeking a Head of Corporate Quality to lead the Global Quality Management System across biologic and digital products, devices, and gene therapies.

You will drive policy development, risk assessment, and regulatory alignment to sustain cGMP and ICH standards while communicating risk to Executive Management. The role requires extensive experience in pharma regulation, change leadership, and building high‑performing teams in a complex, global environment.

Qualifications

• Leadership experience in pharma with regulatory focus.
• Expert knowledge of US/International cGxP, ICH and device regs.
• Auditing experience and familiarity with QA leadership at Director+ level.

Responsibilities

• Lead and manage Biogen's QMS and compliance programs.
• Oversee audits, regulatory responses, and CAPAs across sites.
• Develop metrics and executive updates on QMS performance.
• Collaborate with R&D Compliance and global regulators.
• Drive change and ensure cGMP alignment across products.

Skills

Regulatory leadership

Quality Assurance

cGxP knowledge

FDA/EMEA experience

Leadership

Change management

Communication

Education

Bachelor's degree in related field

Advanced degree preferred

Job description

Biogen, Inc. is seeking a Head of Corporate Quality to lead the Global Quality Management System across biologic and digital products, devices, and gene therapies.

You will drive policy development, risk assessment, and regulatory alignment to sustain cGMP and ICH standards while communicating risk to Executive Management. The role requires extensive experience in pharma regulation, change leadership, and building high‑performing teams in a complex, global environment.