CMO Quality Engineer

Job content

Do you want to work in a biotech company? Do you have at least 2 years experience in CMO Management? You should then read the following lines!

Our client, based in Baar, is looking for a CMO Quality Engineer for a 6 months mission.

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 product stage in focus is Label and Pack activities for originator products.

The CMO Quality Engineer is the point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team

• 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.
• 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
• dentify 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
• 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
• 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
• Identify opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used
• Generate and coordinate continuous improvement projects
  

Requirements

• 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 pharmaceuticals, is a plus.
• Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
• Strong communication skills.
• Ability to work in an international matrix environment.
• Negotiation skills
• Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
  

Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.