Sr Manager, QA Operations
Il y a 2 mois
Take part to the business entity’s growth by ensuring high value products disposition in a controlled manner Be the owner of processes compliance by following daily routine of the manufacturing steps and associated services while partnering and interacting with qualified person and other relevant key positions in all departments.
**Content of the function**
- ** Team**
Coach, lead and contribute to the success of you team
Define resources to be able to execute the daily routine in a timely-manner.
Optimize resources to focus on efficience of the team and their goals.
Be responsible for the training and the understanding on theoretical and practical procedures
- Operational
Review the documentation linked to manufacturing areas
Help to define quality requirements related to projects
Manage and approve all types of quality events linked to their scope
Bring quality expertise for contracts discussions
Be the contact for client and project manager (from master cell/viral banks to filling step)
Coordinate and approve products' documentation (specification sheet, procedures, master batch record, executed batch record,...)
Support and active participation to the audits and inspections
- ** Operational Excellence**
Own the culture of efficiency and quality in their team and contribute to influence all others departments
Made proposals for improvements for manufacturing and/or organisation. Lead by example to have a change mindset with their team.
Made regular on-site visit
Create adequate performance indicators and have a follow up
**Skills**
- Well-versed on EU and US cGMP requirements for clinical and commercial biologics cell/gene therapy manufacturing is an asset
- Capable to understand operational document with the view of compliance, accuracy and exhaustivity requested by GMP
- Customer-centric attitude with business sense
- Ability to advise on regulatory solutions and influence partners
- Soft and hard skills well developed
- Good in communication, written and orally, internal/external
- Fluent in French and English
**Knowledge and level of education**
- Master in a life science field at least with more than 5 years proven experience in pharmaceutical industry
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