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North Carolina, United States
Onsite
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
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
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:
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.