Commercial CMO Quality Lead US (743999834379136)
The main purpose of this job is to manage the Quality Activities with manufacturing and testing partners (CMOs) by ensuring quality of product/process transfers, validations, issues’ investigations, tracking and resolution as well as process improvements.
The responsibilities also include the evaluation of the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements.
The CMO Quality lead is the Biogen point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team.
What You’ll Do
- Quality Operations activities management with key/critical CMOs
- Collaborate actively with key/critical CMO to sustain without disruption the supply chain
- Participate to technology transfer, scale-up or improvements projects through validation
- Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation
- Prepare and Manage Quality management Review, Annual Product Review performance and Quality agreement
- Identify opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used
Who You Are
You are passionate about Quality and use your critical mindset to solve technical and operational issues. You focus on compliance and supply continuity and love working through collaboration.Qualifications
- Minimum Bachelor's degree with 5 years of experience in pharmacuitcal or biotechnology industry, Master degree preferred, in a scientific topic
- Ability to successfully influence the peer level at CMOs
- Able to clearly communicate expectations
- Solid technical knowledge
- Develop and sustain an internal and external networking
- Lead matrix teams and drive project initiatives
- Strong communication skills
- Negotiation skills
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.