Sr Associate II, Technical Quality

Biogen; Milwaukee (WI); On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurances

401(k) program participation with company matched contributions

Tuition reimbursement of up to $10,000 per calendar year

Job summary

Biogen is seeking a Senior Associate II, Technical Quality in Milwaukee, Wisconsin, to ensure quality and compliance across various operations. The role involves leading investigations, managing change controls, and providing oversight for quality control activities.

The candidate should have a Bachelor's degree and at least 5 years of experience in a cGMP environment. Responsibilities include managing deviation investigations, change controls, and serving as a quality representative in cross-functional projects. Comprehensive benefits and competitive salary ranging from $93K to $121K are offered.

Qualifications

• Minimum of 5 years of experience in cGMP biotech or pharma quality.
• Expertise in GMP and quality systems.
• Experience with process validation or QC method validation.

Responsibilities

• Lead and approve deviation investigations.
• Manage change controls related to materials.
• Provide Quality Assurance oversight on laboratory activities.

Skills

GMP and quality systems expertise

Deviation investigation and root cause analysis

Change control management

Regulatory compliance knowledge

Data integrity and laboratory systems knowledge

Education

Bachelor's Degree in relevant field

Job description

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

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.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short‑ and Long‑Term Disability insurance
• 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.