Sr Associate II, Technical Quality

Responsibilities

• 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

Requirements

• 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?
• 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 in

Benefits

Additional Information

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.

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