Global Quality & Compliance Director

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

Benefits offered by this job

Medical, Dental, Vision insurance

Stock purchase plan

Paid time off

Retirement savings plan

Job summary

Biogen seeks Head of Corporate Quality to lead the Global QMS across U.S. and international sites, including cGMP compliance, audits, IT quality, and knowledge management. You will drive risk management, regulatory alignment, and executive communication.

In this hybrid role (RTP or Cambridge base), you will chair the Global Management Review, guide ICH conformance, and oversee multiple product lines, vendors, and cross-functional teams while delivering strategic updates and performance metrics.

Qualifications

• Minimum 15 years of leadership experience in the pharmaceutical industry.
• 10+ years leading a Quality Assurance, Regulatory, or Corporate organization at Director+ level.
• Experience with the FDA, EMEA, and other regulatory agencies.
• Knowledge of US and International cGxPs, ISO, ICH, and device regulations.
• ASQ or other auditing certification is beneficial.

Responsibilities

• Implement integrated quality systems across U.S. and international sites including RTP and Cambridge.
• Develop and maintain a risk assessment process for cGXP systems.
• Oversee external regulatory updates and adapt the QMS as needed.
• Lead GxP and ISO audit programs with risk management oversight.
• Prepare semi-annual executive updates on QMS state and performance.
• Interact with senior regulatory agencies including FDA and EMEA.

Skills

Leadership experience

Regulatory knowledge

Change management

Auditing

Cross-functional collaboration

Education

Bachelor's degree in related field

Job description

Biogen seeks Head of Corporate Quality to lead the Global QMS across U.S. and international sites, including cGMP compliance, audits, IT quality, and knowledge management. You will drive risk management, regulatory alignment, and executive communication.

In this hybrid role (RTP or Cambridge base), you will chair the Global Management Review, guide ICH conformance, and oversee multiple product lines, vendors, and cross-functional teams while delivering strategic updates and performance metrics.