Sr. Associate II, Compliance
Biogen
Compliance / Regulatory
Research Triangle Park, Durham, NC, USA
About This Role
The Sr. Associate II, Compliance plays a critical leadership role in ensuring the RTP Drug Substance Manufacturing site maintains a strong state of compliance and inspection readiness. This position partners closely with Site Leadership and Quality teams to oversee inspection management, data integrity, and quality systems, while driving continuous improvement across local and global processes. This role is instrumental in ensuring adherence to regulatory requirements and strengthening a culture of quality and compliance across the organization.
What You’ll Do
- 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
Who You Are
You are a proactive and detail-oriented quality professional with a strong foundation in compliance and regulatory expectations. You bring a continuous improvement mindset and thrive in fast-paced, highly regulated environments where collaboration and data-driven decisions are essential.
Required Skills
- Bachelor’s degree in scientific, technical, or relevant discipline
- At minimum 5 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
- Strong knowledge of cGMP regulations and global regulatory standards (FDA, EMA, etc.)
- Experience with inspection management, compliance oversight, and quality systems
- Demonstrated ability to analyze data, manage risk, and support regulatory interactions
- Excellent communication, organizational, and problem-solving skills
- Ability to manage multiple priorities and make decisions under pressure
Preferred Skills
- Prior experience in Compliance-focused Quality roles
- Experience with quality systems such as Veeva, TrackWise, and Power BI
- Strong knowledge of data integrity principles and regulatory expectations
- Experience supporting global quality initiatives and cross-functional teams
- Proven ability to drive continuous improvement and influence stakeholders
Additional Information
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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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 DE&I efforts.
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.