Sr Associate II, Technical Quality
Yesterday• Research Triangle Park, NC
About This Role
As a Senior Associate II, Technical Quality, you will play a critical role in ensuring quality and compliance across manufacturing, laboratory, engineering, and quality operations. You will lead and support investigations, change controls, quality oversight activities, and continuous improvement initiatives that strengthen operational performance and regulatory compliance. This position serves as a key technical quality subject matter expert, partnering cross-functionally to solve complex problems, assess risk, and implement effective quality solutions. You will provide quality assurance oversight for quality control activities, technology transfers, material management, and regulatory inspection readiness. This role helps drive a culture of quality, compliance, and operational excellence across the organization.
What You'll Do
- Lead, review, and approve deviation investigations and ensure timely resolution of quality events
- Assess deviation impact, identify root causes, and support effective CAPA implementation
- Manage change controls related to raw materials, supplier changes, and material lifecycle activities
- Provide Quality Assurance oversight of Quality Control operations, laboratory systems, and analytical activities
- Review and approve investigations related to OOS, OOT, atypical, and invalid laboratory results
- Perform material disposition activities in accordance with approved procedures
- Review and approve technology transfer protocols, reports, and technical documentation
- Support internal audits, regulatory inspections, and third-party audits
- Serve as a quality representative on cross-functional projects and continuous improvement initiatives
- Provide technical guidance on GMP compliance, quality systems, and regulatory expectations
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Who You Are
You are a collaborative quality professional who thrives in complex GMP environments and enjoys solving technical and compliance challenges. You are a proactive leader who can influence cross-functional teams, make risk-based decisions, and drive continuous improvement.
Required Skills
- Bachelor's Degree plus minimum of 5 years of experience working in cGMP biotech or pharma quality positions
- GMP and quality systems expertise
- Demonstrated abilities in deviation investigation and root cause analysis
- Experience with process validation or QC method/instrument validation
- Change control management
- Regulatory compliance knowledge (FDA, EMA, ANVISA)
- Data integrity and laboratory systems knowledge
Preferred Skills
- Experience supporting regulatory inspections and audits
- Technology transfer experience
- Experience with enrollment testing and release of raw materials
- Quality Control experience
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 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.
Client-provided location(s): Research Triangle Park, NC
Job ID: Biogen-REQ23573
Employment Type: FULL_TIME
Posted: 2026-06-12T23:51:07
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)