As operational QA manager, your mission is to oversight quality activities in operations: implement, improve and maintain the quality system with related departments (logistic, manufacturing & quality control). You’ll be responsible of a small team helping you to ensure the right quality level within operations. In addition, you will also have a coaching role towards the manufacturing team to build a quality mindset.
- Manager of a small team: ensure team spirit, define priorities, ensure objectives are achieved
- With your team, you’ll be responsible of the following:
- Quality point of contact for all operations related-activities: deviations, change requests, CAPA, documents review, incoming insection….
- responsible of performing internal audits in logistics, manufacturing and quality control to ensure the processes are in place & in use
- improve current processes in place to ensure increase of quality level with real added value for the company.
- release of products (equipment for biotechnologies) after thorough review of production documentation
- QA stakeholder for manufacturing improvement projects
- technical visit of key suppliers to ensure they provide the right quality level
- support of product manager to define & write quality-related documentation for customers
- write procedures & training material defining quality systems to implement in operations
- review & approve procedures and work instructions defining logistics/manufacturing/quality control activities
- As part of QA team, you’ll be process owner of 1 or more quality processes
- support of peers in the quality team when necessary
- MSc in Life Sciences, Bio-Engineering, Engineering or related field
- At least 8 years of experience working in biotechnology/pharmaceutical company (in a GMP environment) or as supplier for those companies
- Experience working with Gene therapy is an asset
- Experience working in operations is an asset
- Experience in change management is an asset
- Strong in communication and team player
- Good influential skills
- Ability to work in fast-paced environments and to combine helicopter view and tactical actions
- Fluent in French and English.