Clinical Supply Operations Manager
3 days ago
The Global Clinical Supply Chain (GCSC) at Biogen is seeking a Clinical Supply Operations Manager to ensure high levels of compliance and effectiveness in its operations. This role will be responsible for managing Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.
This person will build positive connectivity with corporate Quality teams and programs, ensuring effective use of Biogen's change management system PLM. The role will lead corporate initiatives on behalf of GCSC, such as Business Continuity planning and Business Impact Assessments. Additionally, the role will be responsible for knowledge and training management in GCSC.
Key Responsibilities:
- Act as GCSC's project lead for quality-related projects and initiatives.
- Facilitate audits and inspections originating from PO&T (Tech Ops) and Clinical Operations (R&D).
- Develop and maintain quality systems and processes in GCSC.
- Closely collaborate with Clinical Operations Quality team to build clear R&Rs and facilitate seamless quality management.
- Own and execute complex CAPAs and PEs within R&D and PO&T systems.
Requirements:
- Bachelor's degree in a related field with 5-7 years of experience in a CMP/GCP environment.
- Experience in pharmaceutical supply chain environments.
- Experience with Quality Management Systems such as Oracle PLM.
- Broad knowledge of quality operations and process management.
- Excellent written and verbal communication skills in English.
Preferred Qualifications:
- Clinical Supply Chain experience.
- Familiarity with continuous improvement and Lean Six Sigma/DMAIC.
- Experience with ERPs such as Oracle EBS.
About Biogen:
We are a global team committed to excellence and innovation. As a mid-sized biotechnology company, we provide stability and resources while fostering an environment where individual contributions make a significant impact. Our team encompasses talented and passionate achievers who have unparalleled opportunities for learning, growth, and skill expansion. We work together to deliver life-changing medicines, with every role playing a vital part in our mission.
At Biogen, we are dedicated to building a culture of inclusion and belonging that reflects the communities we serve and operate in. We believe that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company. We are focused on building teams where every employee feels empowered and inspired.
Biogen is an E-Verify Employer in the United States and is committed to equal employment opportunity 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 protected characteristic.
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