Senior Compliance Lead: Inspection & Quality Systems

Biogen, Inc.; North Carolina; On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation and holidays

401(k) with match

Job summary

Biogen, Inc. is seeking a Sr. Associate II, Compliance to lead site compliance and inspection activities at the RTP Drug Substance Manufacturing site.

This role partners with Site Leadership and Quality teams to oversee data integrity, risk management, and quality systems in a fast-paced, regulated environment. The successful candidate will drive governance meetings, deliver quality metrics, and ensure readiness for domestic and international regulators while supporting continuous improvement

Qualifications

• Bachelor’s degree in scientific, technical, or relevant discipline.
• 5+ years of Quality Assurance in pharmaceutical, biotech, or manufacturing environments.
• Strong knowledge of cGMP and global regulatory standards.
• Experience with inspection management, compliance oversight, and quality systems.
• Demonstrated ability to analyse data, manage risk, and support regulatory interactions.
• Excellent communication, organisational, and problem-solving skills.
• Ability to manage multiple priorities and make decisions under pressure.

Responsibilities

• Lead site compliance and inspection management activities, including planning, execution, and regulatory response coordination.
• Ensure the site remains inspection-ready at all times for domestic and international regulatory agencies.
• Provide compliance oversight across data integrity, risk management, and quality systems.
• Prepare and facilitate site governance meetings and deliver quality metrics using tools such as Veeva, TrackWise, and Power BI.
• Drive quality management review processes and lead quality metric governance to support data-driven decision making.
• Partner with global quality forums to ensure alignment with the global Quality Management System (QMS).
• Lead and support process and product risk assessments, ensuring timely completion and effectiveness.
• Identify and proactively resolve compliance gaps and technical issues.
• Champion continuous improvement initiatives across quality systems and processes.
• Serve as a key Quality representative on cross-functional teams and site leadership initiatives.

Skills

Quality Assurance

cGMP knowledge

Inspection management

Regulatory interactions

Data analysis

Communication

Organizational skills

Problem solving

Risk management

Cross-functional collaboration

Education

Bachelor's degree in scientific/technical/relevant discipline

Tools

Veeva

TrackWise

Power BI

Job description

Biogen, Inc. is seeking a Sr. Associate II, Compliance to lead site compliance and inspection activities at the RTP Drug Substance Manufacturing site.

This role partners with Site Leadership and Quality teams to oversee data integrity, risk management, and quality systems in a fast-paced, regulated environment. The successful candidate will drive governance meetings, deliver quality metrics, and ensure readiness for domestic and international regulators while supporting continuous improvement