Job Description

About This Role

This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be responsible for the strategic and tactical oversight of batch documentation review, continual evaluation during batch production, as well as providing material acceptance decisions for production batches. Through your guidance, your team will ensure compliance to all applicable regulatory requirements and that all GMP activities consistently operate in a state of control so as to successfully undergo domestic and international regulatory agency scrutiny.

What You'll Do

• Manage a wide variety of compliance oversight activities expanding several quality subsystems to ensure the safety, efficacy, and purity of the products manufactured by Biogen in the SSM, FVM and Cell Banking areas.


• Plan, implement, and direct core functions of QA Managers and Supervisors related to site disposition management and all disposition-related activities. Provide assessment of batch acceptance and perform final batch disposition decision for clinical and commercial production batches.


• Proactively identify and resolve both technical and compliance issues/gaps, Quality system evaluations, and continuous improvement initiatives. Develop and implement aspects of various Quality Systems and system improvements.


• Analyze and present on departmental and site metrics for compliance. Track and trend key performance indicators and evaluate site performance against these KPIs. Communicate with the Head of Quality in regard to any concerns or risks at the site.


• Participate effectively in a leadership or membership role for both corporate, global, and site cross-functional teams as a representative of Quality Assurance. Ensure optimum team dynamics and results.


• Provide mentorship and training within and across site functions.

Who You Are

You are an experienced and energetic leader that enjoys leading a Quality Assurance organization through deadline driven initiatives. You are unfazed by the challenges of a complex manufacturing floor and can effectively plan, communicate, and advocate for a "Quality Mindset" throughout all of operations.

Qualifications

• Bachelors Degree in a relevant Life Sciences or related discipline + a minimum of 10 years of transferrable experience


• Advanced knowledge of quality systems; particularly lot dispositioning, document lifecycle management, change control and exception management


• A strong and successful foundation of experience formally leading Quality Assurance teams in Pharmaceutical or Biotechnology production setting


• Deep knowledge of FDA/EMEA regulations and compliance


• Expertise in solving complex problems or diverse scope

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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.