Sr. Associate III, Compliance

$111k - $149k

Biogen Inc

This senior compliance role at the Research Triangle Park manufacturing site focuses on data integrity and regulatory adherence across Quality and Manufacturing. The position leads compliance initiatives, oversees electronic records and computerized systems, manages inspections, and drives cross-functional improvements aligned with FDA and global cGMP standards. Requires a bachelor's degree, 6+ years of QA experience in regulated environments, and expertise in 21 CFR Part 11 and data integrity principles.

Responsibilities

Lead data integrity compliance initiatives across manufacturing and Quality Control operations
Ensure adherence to global regulatory requirements including 21 CFR Part 11, Annex 11, and cGMP standards
Monitor equipment, instrumentation, and computerized systems for electronic record compliance
Support site inspection management including scheduling, execution, and regulatory response coordination
Develop and deliver data integrity training and awareness programs across the site

Requirements

Bachelor's degree in scientific, technical, or related discipline
Minimum 6 years Quality Assurance experience in pharmaceutical, biotech, or manufacturing
Deep expertise in data integrity principles and FDA 21 CFR Part 11 regulations
Experience with computerized systems, electronic records, and system-based reviews
Proficiency with Quality Control environments and quality systems
Strong analytical, organizational, and communication skills
Ability to manage multiple priorities and drive results under pressure

Compensation: $111,000.00-$149,000.00 base

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Vacancy posted a month ago

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