Data Integrity & Compliance Lead, GMP/Regulatory

Biogen, Inc.; North Carolina; On-site; USD 111,000 - 149,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Paid vacation & holidays

Job summary

Biogen, Inc. is seeking a Sr. Associate III, Compliance - Data Integrity to lead data integrity initiatives at the RTP Drug Substance Manufacturing site.

You will collaborate with Quality, Manufacturing, and Site Leadership to strengthen systems, ensure regulatory readiness, and drive continuous improvement in a highly regulated environment. The role emphasizes data integrity oversight, inspection readiness, and governance with tools like Veeva, TrackWise, and Power BI.

Qualifications

• Bachelor’s degree in scientific, technical, or relevant discipline.
• Minimum of 6 years of QA experience in pharmaceutical, biotech, or manufacturing.
• Strong data integrity and regulatory knowledge (FDA 21 CFR Part 11, cGMP).
• Experience with computerized systems, electronic records, and system-based reviews.
• Experience with Quality Systems in QC environments.

Responsibilities

• Lead data integrity compliance initiatives across manufacturing and Quality Control environments.
• Ensure compliance with global regulatory requirements including 21 CFR Part 11, Annex 11, and cGMP standards.
• Monitor equipment, instrumentation, and computerized systems to ensure data integrity.
• Support site inspection management including scheduling, execution, and regulatory response coordination.
• Approve and support data integrity-related deviations, CAPAs, and change controls.
• Lead data integrity risk assessments and continuous improvement initiatives.
• Develop and deliver data integrity awareness and training programs.
• Prepare and facilitate site governance meetings with quality metrics using Veeva, TrackWise, and Power BI.
• Collaborate cross-functionally to support quality systems, regulatory readiness, and business objectives.
• Drive a strong culture of compliance and data integrity across the RTP site.

Skills

Data integrity

Regulatory compliance

FDA 21 CFR Part 11

GxP knowledge

Quality Assurance

Cross-functional collaboration

Analytical skills

Communication skills

Prioritization

Education

Bachelor's degree

Advanced degree (MS/MBA)

Tools

Veeva

TrackWise

Power BI

Job description

Biogen, Inc. is seeking a Sr. Associate III, Compliance - Data Integrity to lead data integrity initiatives at the RTP Drug Substance Manufacturing site.

You will collaborate with Quality, Manufacturing, and Site Leadership to strengthen systems, ensure regulatory readiness, and drive continuous improvement in a highly regulated environment. The role emphasizes data integrity oversight, inspection readiness, and governance with tools like Veeva, TrackWise, and Power BI.