Sr. Associate III, Quality Assurance (Quality Systems)

Sr. Associate III, Quality Assurance (Quality Systems)

About This Role

As a Sr. Associate III, Quality Assurance (Quality Systems), you will play a pivotal role in ensuring the compliance and efficiency of quality systems at our Biogen RTP facility. Your expertise will be vital in overseeing Quality Control compliance of exceptions and CAPAs, contributing to the issuance and management of GMP documents, and supporting internal operations. This role is integral to maintaining GMP standards and will involve collaborating across functions to drive continuous improvement and global alignment. You'll be responsible for authoring key site reports and facilitating critical meetings and governance boards. Your contributions will support regulatory inspections, audits, and the overall compliance framework, making a significant impact on our business and its operations.

What You’ll Do

• Ensure compliance of Quality Control exceptions and CAPAs with site, corporate, and regulatory standards.
• Review and approve site-specific GMP documents and manage document change controls for RTP sites.
• Contribute to the oversight of quality systems and site performance monitoring systems.
• Issue Batch Production Records, Solution Lot Records, Labels, and Logbooks.
• Identify and implement improvements in Quality Systems.
• Develop and deliver training on basic GxP quality systems and provide mentorship.
• Prepare for and support site inspections and audits.
• Make timely and effective decisions for Quality Systems management.
• Analyze metrics and propose solutions to improve existing Quality Systems.
• Serve as a site contact for global quality system meetings and projects.
• Author GMP procedures and ensure compliance with industry standards.
• Facilitate meetings with senior leadership and coordinate cross-departmental activities.

Who You Are

You are a decisive and knowledgeable professional who thrives in a dynamic quality assurance environment. Your ability to make autonomous decisions and tackle complex tasks independently sets you apart. You possess a keen eye for identifying compliance gaps and have a knack for creative problem-solving. With your strong organizational and communication skills, you manage multiple projects seamlessly and interact effectively with senior management. You are proactive in supporting strategic quality initiatives and have a comprehensive understanding of quality systems.

Required Skills

• Bachelors Degree (scientific/technical preferred) plus a minimum of 7 years of Quality experience in a regulated, biotech/pharma environment.
• Proficient understanding of internal quality systems and requirements.
• Demonstrated experience training and mentoring teammates.
• Ability to work independently.
• Strong oral and written communication skills.
• Demonstrated leadership abilities and complex problem-solving skills.
• Knowledge of FDA/EMEA regulations and compliance.
• Strong organizational skills and ability to multitask.

Additional Information

The base compensation range for this role is: $109,000.00-$146,000.00. 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

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.