Sr Associate II, Quality Assurance Operations
Biogen
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
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
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.