A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role :
As the Head of Quality, you will ensure the respect of Quality Systems & processes as required by current GMP. You will organize and supervise pharmaceutical operations and assure permanent compliance with the French Public Health code by delegation of the Responsible Pharmacist.
As a manager of the Quality Assurance and Quality Control departments you ensure the creation/update and monitoring of harmonized systems between departments.
You represent Semoy site in the relations with the authorities during inspections (Ansm, FDA, MHLW JP, Anvisa...), during audits (internal quality and external customers when acting as a CMO) and decline the Group Quality objectives in the site.
You also supervise and/or prepare annual assessments for applicants (Site Master File, Registration...).
With your team (approx 80p in total) you manage the analysis and treatment of Customer complaints, the implementation of annual validation plans and audits. You monitor regulatory aspects, guarantee the compliance of Drug Products according to Marketing Authorization Dossier, supervise the release or rejection of batches process and detect non-compliance risks by implementing preventive actions.
Please submit your application in English.
Who you are :
- Pharmacist with previous experience of min 10 years as Responsible Pharmacist or Delegated Pharmacist on a manufacturing site
- Work experience in pharmaceutical or chemical industry required
- Demonstrated ability to manage multi-disciplinary teams in an international and matrix company
- Strong experience in implementing and maintaining Quality excellence processes and operational actions in a production site(s)
- Fluency in English is mandatory
What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!