Supplier quality manager Jobs in Irvine, CA

We are seeking a Senior Manager Supplier Quality responsible for overseeing the quality management of procured materials (APIs excipients intermediates packaging materials) in compliance with applicable internal and external requirements (GxP ISO) while developing implementing and improving related systems processes and procedures.  What You Will Do :

• Drive the quality oversight of the allocated portfolio of procured materials throughout their lifecycle ensuring the timely and effective implementation of the SANTEN operational management model coordinating and following up on change requests and resolving any quality events to prevent recurrence.
• Identify and implement continuous quality improvement plans monitor performance follow up on audit CAPAs and assess prevent and mitigate risks while making and communicating appropriate timely recommendations for quality decisions.
• Develop and implement quality agreements and other contractual agreements related to quality manage supplierrelated projects for quality aspects and ensure the proper selection qualification or disqualification of suppliers with effective oversight of suppliers sterilization sites.
• Contribute to the development and implementation of stateoftheart supplier management processes procedures tools and best practices.
• Lead or participate in supplier external audits and selection visits take responsibility for QP declarations and the material parts of Product Quality Reports.
• compile APIrelated regulatory documents (including CE marking) and address queries from regulatory authorities.
• Lead crossfunctional initiatives proactively support colleagues and peers and collaborate closely with other SANTEN entities and functions.

Qualifications :

Deadline

Please apply by 4th March 2024.

To submit your application please upload your English version of CV (click on Apply and follow the instructions) as we dont accept CVs sent directly.

Additional Information :

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our longterm vision outlined in Santen 2030 we are committed to be a Social Innovator addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin / ancestry religion sexual orientation gender gender identity / expression age disability medical condition marital status veteran status or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.

Remote Work : Employment Type :

Fulltime

Key Skills

Project / Program Management,Change Management,Succession Planning,Procurement,Program Management,ISO 9001,Lean Six Sigma,Quality Systems,Quality Management,Supplier Management,HACCP,As9100

Vacancy : 1