Manager - Governance Risk Control WorldWide Medical Affairs
Manager - Governance Risk Control WorldWide Medical Affairs
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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 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 .
What Youll 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 buyin 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 selfmanage your work. You take accountability quickly and appropriately. You can deal with highpressure situations and are comfortable communicating to senior leadership and external stakeholders.
Qualifications :
Required Skills and Qualifications
- Bachelors 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 $104000 $168000. 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 Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
