Sr. Associate III, Compliance
Biogen•Research Triangle Park, NC
•$111,000 - $149,000
About The Position
The Sr. Associate III, Compliance - Data Integrity is a key leadership role supporting the RTP Drug Substance Manufacturing site, with a strong focus on ensuring data integrity, compliance, and inspection readiness. This individual partners across Quality, Manufacturing, and Site Leadership to strengthen data integrity practices, oversee quality systems, and ensure adherence to global regulatory standards. The role plays a critical part in driving a culture of compliance, continuous improvement, and operational excellence across the site.
Requirements
- Bachelor’s degree in scientific, technical, or relevant discipline
- At minimum 6 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
- Strong knowledge of data integrity principles and applicable regulations (e.g., FDA 21 CFR Part 11, cGMP)
- Experience with computerized systems, electronic records, and system-based review processes
- Experience working with Quality Systems, particularly within Quality Control environments
- Strong analytical, organizational, and communication skills
- Ability to manage multiple priorities, make decisions under pressure, and drive results
Nice To Haves
- Advanced degree (MS, MBA, or related field)
- Experience leading data integrity programs or initiatives in a GMP-regulated environment
- Familiarity with systems such as Veeva, TrackWise, and Power BI
- Experience supporting regulatory inspections and audit responses
- Strong stakeholder management and cross-functional collaboration skills
- Demonstrated ability to drive continuous improvement initiatives in quality systems
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 compliance with electronic record and data integrity standards
- Support site inspection management activities including scheduling, execution, and regulatory response coordination
- Approve and support data integrity-related deviations, CAPAs, and change controls
- Lead and contribute to data integrity risk assessments and continuous improvement initiatives
- Develop and deliver data integrity awareness and training programs across the site
- Prepare and facilitate site governance meetings and provide quality metrics using tools such as 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
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
