Global Quality & Compliance Leader, cGMP & Audits

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Employee stock purchase plan

Tuition reimbursement

Paid vacation

Job summary

Biogen seeks a seasoned Head of Corporate Quality to lead the Global QMS, overseeing cGMP compliance, audits, IT quality, product complaints, and knowledge management. This hybrid role supports RTP or Cambridge-based operations and interfaces with R&D Compliance and executive management.

The candidate will drive risk management, regulatory change adaptation, and executive updates on QMS performance. Strong leadership, communication, and change-management skills are essential.

Qualifications

• Bachelor’s degree in a related field with 15+ years of leadership experience in pharma.
• 10+ years leading a Quality Assurance, Regulatory, or Corporate organization at Director+ level.
• Experience with FDA, EMEA and other regulatory agencies.
• Experience with clinical and commercial products across large/small molecules, devices, and combos.
• Quality/compliance experience aligned with global regulatory requirements.
• Expert knowledge of US and international cGxPs, ISO, ICH, and device regulations.
• Ability to hire and retain top talent and develop leaders.
• Strong knowledge of product development processes and ICH/device regulations.
• Ability to influence organization through Biogen leadership competencies.
• Proven change management and excellent communication skills.
• Preferred: Advanced degree (PharmD/PhD).

Responsibilities

• Implement integrated quality systems and standards across Biogen sites and PO&T locations.
• Develop risk assessment process for evaluating cGXP systems.
• Holistically assess regulatory inspection responses.
• Set goals and metrics aligned with industry benchmarks for cGMP compliance.
• Oversee external regulatory updates and integrate into QMS.
• Manage internal/external GxP and ISO audit programs with risk oversight.
• Ensure sites and vendors operate in cGMP compliance and escalate risks.
• Oversee IT GxP systems and lifecycle documentation.
• Manage documents lifecycle and archive GXP records; multilingual GMP content.
• Oversee PO&T training program and global guidance for GxP training.
• Lead GMR, present biannual QMS updates, define strategic goals, monitor results.

Skills

Leadership experience

Regulatory experience (FDA/EMEA)

cGxP / ISO / ICH knowledge

Product development knowledge

Change management / communication

Talent management

Device regulations experience

Auditing certification (ASQ)

Education

Bachelor’s degree in related field

Advanced degree (PharmD/PhD)

Job description

Biogen seeks a seasoned Head of Corporate Quality to lead the Global QMS, overseeing cGMP compliance, audits, IT quality, product complaints, and knowledge management. This hybrid role supports RTP or Cambridge-based operations and interfaces with R&D Compliance and executive management.

The candidate will drive risk management, regulatory change adaptation, and executive updates on QMS performance. Strong leadership, communication, and change-management skills are essential.