Sr. Associate II, Quality Control (External Testing Management)

Job Description

About This Role

Biogen is seeking a dynamic professional to oversee all activities related to external Quality testing, with a focus on managing Contract Laboratory Organizations (CLOs). This role drives the development and upkeep of key agreements—including Quality Agreements, MSAs, and SOWs—while leading RFPs, purchase orders, budget tracking, and timeline oversight for outsourced testing. You’ll be the project manager across multiple teams, ensuring alignment on testing status, resolving deviations, and contributing to strategic initiatives like Annual Product Reviews and business performance evaluations. Reporting into Quality Control leadership, you’ll collaborate cross-functionally with Procurement, Finance, Quality, Supply Chain, and more, playing a vital role in maintaining compliance and optimizing vendor performance. This is a high-impact role for someone who thrives on coordination, communication, and continuous improvement in a complex matrix environment.

What You'll Do

• Lead the development, negotiation, and maintenance of Quality Agreements, Master Service Agreements, and Statements of Work with Contract Laboratory Organizations (CLOs)
• Manage financial aspects of external testing including purchase order creation, spend tracking, and budgeting / budget reforecasting
• Monitor progress of outsourced testing activities, ensure timely delivery of results, and communicate status updates across functional teams
• Investigate and resolve testing exceptions, deviations, and compliance issues related to CLO activities
• Serve as the primary Quality point of contact for CLO performance monitoring, issue escalation, and business reviews
• Actively participate in program-level Asset and/or Quality Sub-Team meetings to represent external testing interests
• Collaborate cross-functionally with Procurement, Finance, Corporate Quality Auditing, QC Analytical Technology, and Supply Chain Planning
• Support Annual Product Review by contributing CLO-related performance data and testing summaries
• Identify and implement process improvements to enhance efficiency, compliance, and communication across CLO operations
• Ensure robust information management and documentation practices to support audit readiness and regulatory compliance

Who You Are

You are a skilled communicator and organized project manager with experience overseeing external lab testing in a regulated pharmaceutical environment. You thrive in cross-functional settings, excel at managing vendors and contracts, and demonstrate strong attention to detail when managing compliance, timelines, and continuous improvement.

Qualifications

Required Skills

• Bachelor's degree plus minimum of 5 years of experience working in a cGMP Biotech/pharma Quality Control environment OR biotech/pharma finance environment
• Previous experience in contract and/or vendor management
• Project management skills
• Deep understanding of quality and compliance
• Demonstrated cross-functional collaboration abilities
• Strong verbal and written communication skills and information management skills

Preferred Skills

• Experience using the following software/programs: Veeva, Oracle, PLM, Excel, OneNote

Additional Information

The base salary range for this position is $91,000- 118,000 annually. 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.