Global Head of Quality & Compliance

Biogen; North Carolina; Hybrid; USD 281,000 - 397,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurr

Fitness & Wellness programs includinga

Short- and Long-Term Disability

Paid vacation and holidays

Sick time

Paid Maternity and Parental Leave

401(k) with company matched

Employee stock purchase plan

Tuition reimbursement up to $10,000

Employee Resource Groups

Job summary

Biogen seeks a Head of Corporate Quality to lead the Global Quality Management System, oversee cGXP compliance, and manage audits of vendors, CMOs, IT quality, and product complaints. The role aligns with PO&T and reports to executives, requiring cross-functional leadership across US and international sites.

The position emphasizes risk management, regulatory updates, and strategic QMS improvements, with a hybrid work model in RTP or Cambridge-based locations and regular executive updates.

Qualifications

• Bachelor’s degree in a related field with 15+ years of leadership experience in the pharmaceutical industry.
• 10+ years leading a Quality Assurance, Regulatory, or Corporate organization at the Director+ level in a highly regulated environment.
• Experience with the FDA, EMEA, and preferably multiple additional regulatory agencies in other foreign countries.
• Knowledge of US and International cGxPs, ISO, ICH, and Device regulations.

Responsibilities

• Implement integrated quality systems across Biogen manufacturing sites and PO&T locations.
• Develop and maintain a risk assessment process for evaluating and monitoring all cGXP systems.
• Oversee external monitoring of regulatory updates and incorporate changes into Biogen’s QMS.
• Prepare semi-annual executive updates on the state of Biogen’s QMS and related risks.
• Lead the GMR and ensure compliance with cGMP and ICH expectations.

Skills

Leadership

Regulatory experience

Communication

Change management

Risk management

Education

Bachelor’s degree in related field

Advanced degree (PharmD, PhD)

Job description

Biogen seeks a Head of Corporate Quality to lead the Global Quality Management System, oversee cGXP compliance, and manage audits of vendors, CMOs, IT quality, and product complaints. The role aligns with PO&T and reports to executives, requiring cross-functional leadership across US and international sites.

The position emphasizes risk management, regulatory updates, and strategic QMS improvements, with a hybrid work model in RTP or Cambridge-based locations and regular executive updates.