For our client, a global leader in the development of animal health products and services, we are looking for a
Third Party Quality Assurance Manager - API, (m/w/d)
The Third Party Quality Assurance Manager API is responsible for the quality oversight of assigned API contract manufacturer organizations (CMOs) and suppliers. He ensures that the delivered APIs from partners meet all legal and internal requirements.
The primary responsibilities of this position include: using quality systems to ensure API CMOs/Suppliers oversight; ensuring compliance with appropriate regulatory and company requirements; providing QA guidance and advice to all functions within the EEM API Network; and effective partnership with the EEM API Network leadership, other EEM hubs, internal manufacturing sites, and all other functions integral to the supply of APIs to the various business nodes.
- Ensure that external API manufacturers manufacture, test and release APIs in compliance to GMP, the marketing authorization and Elanco internal requirements.
- Manage all assigned QA related projects within the API Network as analytical method transfers and validations in collaboration with internal and external laboratories and external API CMOs/Suppliers.
- Support all regulated change control activities within the API network activities, provide QA related expertise in compliance with regulatory and GMP requirements.
- Participate as QA API function in launch projects to ensure the timely launch of new products implementing new APIs and API sources according to the registered set-up.
- Manage and drive a constructive communication with external API CMOs and /Suppliers. Facilitate an open communication and cooperation with high integrity.
- Evaluate and support the remediation of any quality related issue and non-conformity at an external API partner and drive continuous improvement initiatives.
- Support and guide internal functions and external partners on any QA and QC related activities (e.g training, issue, resolution, interpretation of standards, inspection readiness, etc).
- Drive the utilization of Risk Management principles for API CMOs/Suppliers oversight and monitor API CMOs/Suppliers QA performance metrics and reports.
- Maintain knowledge of the business, regulatory, and quality landscape for all APIs in the portfolio
EDUCATION & EXPERIENCE
- Master's Degree or higher in chemistry or pharmacy or a related discipline is required.
- A minimum of 8 years of GMP experience in the quality control, quality assurance or production of the API or pharmaceutical industry.
- Strong knowledge of chemical or pharmaceutical quality control, chemical processes, and analytical technologies within current regulatory requirements and GMP.
- Excellent written and oral communication that facilitates and drives the interaction with external partners. Effective collaboration and communication with various cultures, languages, work styles, and levels within a global organization and environment.
- Demonstrated problem solving, quality risk management and decision making skills within the regulated environment of the API or pharmaceutical industry.
- English - read, write, and speak fluently
- English: technical and scientific writing and documentation capabilities meeting the standard of Health Authorities reviewers.
- German - read, write, and speak fluently
- Previous line-management experience is desired.
- Proficiency in other languages is beneficial.
Start date: As soon as possible, notice period is also ok
Actual End Date (permanent position)
Place of work: Basel
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Stefanie Bucheli +41 61 270 80 17.
We are looking forward to getting to know you!