Sr Associate II, Quality Assurance Operations
Yesterday• Research Triangle Park, NC
This is a full time, on-site position at our RTP facility with standard M-F business hours and occasional off-hours support
About This Role
As a Sr. Associate II in Quality Assurance, you will play a pivotal role in overseeing the quality strategy for our assigned internal programs and manufacturing operations at the RTP PHARMA site. You will ensure the coordination of key tactical and operational aspects, supporting batch record review, disposition, investigations, change controls, and handling post-release activities. Your expertise will drive the review and approval of critical documents, including batch reports and technology transfer documents, ensuring compliance with regulatory requirements. Your contributions will be integral to maintaining adherence to Biogen policies, managing quality projects, and interfacing with key partners to uphold regulatory standards.
What You'll Do:
- Oversee the Quality strategy for assigned programs and manufacturing operations
- Coordinate with other line functions to ensure tactical and operational aspects within QA
- Support batch record review and disposition, ensuring compliance
- Review and approve investigational reports and GMP documentation
- Drive the review and approval of batch/campaign reports and technology transfer documents
- Assist in the development of Global Quality Systems and provide quality oversight
- Mentor and train peers within the Quality Assurance function
- Participate in audits, inspections, and cross-functional improvement initiatives
- Manage Quality projects and adhere to regulatory licenses and regulations
- Interface with key Quality, tech transfer, and manufacturing partners
- Ensure systems within the Quality Assurance department comply with cGMP standards
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Who You Are:
You are a detail-oriented professional with the ability to navigate complex issues and shift priorities as necessary. You possess a robust understanding of quality concepts and are adept at developing innovative solutions to challenges. Your strong organizational skills allow you to multi-task and coordinate activities efficiently. With excellent written, verbal, and interpersonal communication skills, you can articulate recommendations and decisions to Quality Management effectively. Your ability to mentor others and drive collaboration across functions makes you an invaluable asset to the team.
Required Skills:
- Bachelor's Degree in Life Science or other related discipline
- Minimum 5 years (or Associate's plus 7 years) of experience working in quality assurance within a pharmaceutical or biotech manufacturing environment
- Experience reviewing and approving batch records
- Well versed in conducting and approving investigations
- Solid understanding of relevant FDA/EMA regulations and compliance
- Strong organizational skills with the ability to multi-task
- Excellent written, verbal, and interpersonal communication skills
- Competency in enterprise computer applications
Preferred Skills:
- Drug substance manufacturing and/or release
- Experience working in ASO highly desired
- Experience in clinical label and pack
- Experience in a syringe and/or cartridge manufacturing environment
Job Level: Professional
Additional Information
The base compensation range for this role is: $93,000.00-$121,000.00
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.
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.
Client-provided location(s): Research Triangle Park, NC
Job ID: Biogen-REQ22937
Employment Type: FULL_TIME
Posted: 2026-03-30T23:52:27
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)