Job Detail

Job Description

1.  Accountable on CMOs oversight

• Quality Operations activities management with key/critical CMOs


• Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.


• Develop knowledge of the manufacturing line at key/critical contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SME


• Collaborate actively with key/critical CMO to sustain without disruption the supply chain


• Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations


• Participate to technology transfer, scale-up or improvements projects through validation and on-site presence


• Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation


• Contribute to Regulatory inspection including needs of Biogen presence, review of observations, responses and action plan follow-up


• Prepare and Manage Quality management Review, Annual Product Review performance and Quality agreement


• Support recall management.

2.  Quality System

• Identify and drive improvements/updates of the GMP documentation related to QE activities


• Identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issue


• Support local Quality system (change control, deviations, CAPAs, …) as required


• Ensure adherence to serialization and data integrity requirements

3.  Communication & Build Strategic Work relationship

• Identify and timely communicate to the management any supply risk or risk of batch rejection


• Ability to successfully influence the peer level at CMOs.


• Able to clearly communicate expectations to internal/external customers as well as management or peers


• Able to report status of ongoing activities to the manager/stakeholder, highlight any time constraints and propose action/time reallocation to the manager


• Develop and sustain an internal and external networking

4.  Decision Making

• Solves technical and operational problems in field of expertise based on existing policies, procedures and solutions Makes operational decisions within scope and accepts full accountability of decisions made, but also recognizes when to escalate.


• Prepares and presents information contributing to reject/recall decisions.


• Ability to back-up peers for area of expertise

5.  Developing Others

• Leads matrix teams within a product program cross functionally or at global level. May also drive project initiatives.


• Coach peers, coach other departments on quality regulations and tools, delegate and empower appropriately and build core skills and abilities.


• May assist junior team members in the comprehension of team goals

6.  Innovation/Pioneer

• Identify opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used


• Generate and coordinate continuous improvement projects

Qualifications

• Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).


• A minimum of 5 years of experience in pharmaceutical or biotechnology industries


• Relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus);


• Knowledge of medical device regulations and unit operations for manufacturing of either parenterals or parmaceuticals, is a plus.


• Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.

Additional Information

The main purpose of this job is to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner 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 role also includes quality management of the product lifecycle management in relation with contract manufacturing, artworks and support to asset functions such as review and approval of regulatory filings.

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