Sr. Associate III, Compliance

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

About this role

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.

What you’ll do

• 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

Who you are

You are a detail-oriented quality professional with deep expertise in data integrity and regulatory compliance. You bring a proactive, solutions-focused mindset and are comfortable working cross-functionally to drive improvements in highly regulated environments.

Required skills

• 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

Preferred skills

• 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

Job Level: Management

Additional Information

The base compensation range for this role is: $111,000.00-$149,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

Read on to learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.