Job Description

About This Role

The Manager - Governance, Risk, & Control ((WorldWide Medical Affairs) is a part of the Global Medical Capabilities Team, a strategic partner within Worldwide Medical Affairs.  This role will support the regulatory (e.g. GxP, Data Integrity, Pharmacovigilance, etc.) quality oversight program for Medical worldwide.  This position will provide ongoing support and guidance on the execution of all regulatory quality risk management and mitigation activities within assigned Medical functions. This role will engage across all functions of Medical and the Company including global and affiliate personnel, Global Safety and Regulatory Sciences, Research & Development (R&D), and Audit Teams to effectively promote consistent and coordinated quality execution. 

What You'll Do

• Provide guidance and collaborate with Process Owners in the development and maintenance of regulatory quality related processes and relevant risk management initiatives.
• Support regulatory inspections, audits, deviation, and CAPA management including, root cause analysis, resolution design, timeliness of implementation, effectiveness checks, etc.
• Contribute to the upkeep and management of tools to track and report key quality metrics.
• Represent Worldwide Medical Affairs in company regulatory quality forums (e.g., Quality Community of Practice, inspection preparation teams), ensure cohesive inclusion of Medical with related Company functions and processes (e. g. drug safety, regulatory, R&D Quality).
• Create awareness and buy-in at all functions and levels of Medical on regulatory processes and quality management concepts, best practices, and strategic relevance.
• Represent Worldwide Medical Affairs in different Quality initiatives as needed. 
• Ensure, in coordination with key Learning Teams, a robust GxP and regulatory quality training for appropriate functions.

Who You Are

You are someone who works well in a Global Team and has the ability to self-manage your work.  You take accountability quickly and appropriately. You can deal with high-pressure situations and are comfortable communicating to senior leadership and external stakeholders.

Qualifications

Required Skills and Qualifications

• Bachelor's Degree in relevant life sciences is required.
• Strong knowledge of Quality Management System related processes is required, such as: Quality issue and CAPA management, Training management, Controlled document management.
• Experience working with and ability to apply GxP regulatory guidelines, e.g., Good Clinical Practice (GCP) guidelines, EMA GVP Module VI, US FDA 21 CFR Part 11, or other regional equivalents is required.
• Demonstrated strong ability to identify, analyze, and solve problems is required.
• Strong communication, interpersonal, and customer service skills is required.
• High degree of technical/system acumen is required.
• Highly organized, with attention to detail and good project management skills required.

Additional Information

The base compensation range for this role is $104,000 - $168,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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.