Sr. Associate III, Quality Assurance (Inspection Readiness)

Job Description

This is a full time, on-site position

About This Role  

This position will support our drug substance (Bio) site at our Research Triangle Park NC facility. The primary responsibilities of the Senior Associate III include quality compliance for managing site inspections, completing regulatory requests for partner and Biogen products, authoring Site Reports (Site Management Review Report and Site Master File), change control support, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation.

What You’ll Do  

• Management of regulatory and partner inspections and regulatory requests for the RTP DS (Bio) site through inspection set up, inspection team support, response management, closure of inspection workflows, and identifying overall inspection trends.
• Lead site inspection activities through planning and readiness related to inspection schedule, execution and response activities.
• Process and complete regulatory requests in a timely manner to support regulatory submissions and approval status across several markets.
• Serve as quality oversight on regulatory responses in the quality system. Provide quality oversight of adequate documentation and on time closure of audit responses to any inspection findings.
• Identify and implement Quality System improvements.
• Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.
• Other duties as assigned.

Qualifications

• Bachelor’s degree required, science related field preferred
• Minimum 7 years of industry experience in a GMP/cGMP environment within pharmaceutical or biotech manufacturing 
• Expert knowledge of FDA/EMEA regulations and compliance
• Expertise in managing and conducting audits
• Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions or globally (Coordinates activities across these groups to complete compliance activities)
• Project management experience, including strong organizational skills and ability to multi-task and coordinate multiple activities in parallel
• Strong oral and written communication skills; ability to communicate with peers and subordinates effectively

Additional Information

The base salary range for this position is $109,000 - 146,000 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.