Quality Assurance responsible for Biosimilars Business Unit with global responsibilities to oversee and implement applicable Quality Management Systems.
The QA responsible is the Alliance Lead for Quality responsible for assuring compliance with quality related contractual obligations with Alliance Partner as well as overseeing and coordinating respective matters and communication.
Responsible for integration/harmonization of Biosimilars QMS to Biogen Quality or R&D QMS as applicable.
Accountability Description:
1. Alliance Lead for Quality
· Lead all communications and interactions with the Alliance partner on quality matters
· Ensure department’s processes and oversight meets contractual obligations with Alliance Partner
· Coordination of reporting to Alliance Partner / MAH and stakeholders
· Oversees QMS data analysis and metric reporting to applicable stakeholders
· Oversee quarterly reporting to MAH on PSMF relevant data
· Ensure alignment of the different department functions on quality matters (namely medical, Safety, Business operations, PO&T and Regulatory)
2. Responsible for department’s relevant Quality Management System:
• Oversee development and review department’s owned GxP procedures
• Ensure that organization is always GxP audit ready. Is the lead auditee for the organization and coordinates responses and CAPAs with Biogen stakeholders and auditor
• Ensure Training assignment all relevant Biogen stakeholders on department’s specific SOPs. Ensures maintenance and management of training of BBU staff and partners
• Deviation and CAPA approval and follow up for Hub GxP activities
3. Vendor Management:
• Coordinate relevant vendor qualification and GxP audit management; support GxP audit follow-ups and CAPAs
• Manage Quality Agreements with vendors, and monitors partner’s performance against them, ensuring proper processes and procedures are implemented to meet Biogen and MAH/Alliance partner requirements
• Oversee vendors’ relevant deviation and CAPA management
• Support and manage Change Controls
• Ensure partner training documentation is developed and kept appropriately
4. Coordinator of Biosimilar complaints and External Temperature Excursions
· Biogen coordination of activities associated with Complaints and Adverse Events from National Health Authorities
· Ensure timely submission of AEs and TPCs to the MAH
· Management of incoming cases received from the MAH: perform case investigation, monitoring correct CAPA follow up for established root cause; Review and approve cases, ensuring global consistency and compliance.
· Coordination with MAH on diffusion of Complaint reporting for Biogen Affiliates.
5. Continuous Improvement:
· Identify and drive the improvement of GxP processes and QMS in line with company direction.
· Ensure harmonization/integration of department’s QMS to Biogen Quality/R&D QMS as appropriate.
Quality Assurance responsible for Biosimilars Business Unit with global responsibilities to oversee and implement applicable Quality Management Systems.
Office based in Baar, Switzerland