As a Third Party Quality Assurance Manager API you are responsible for the quality oversight of assigned API contract manufacturer organizations (CMOs) and suppliers within Elanco’s API network. You ensure that the delivered APIs from Elanco’s API partners meet all legal and internal Elanco 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.
As a Third Party Quality Assurance Manager API you act with integrity and proactively partner with your Elanco colleagues to perform the QA oversight on assigned external partners ensuring that EEM API Network consistently provides compliant, quality APIs, processes, and services to their customers.
-Ensure that Elanco’s 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 Elanco’s 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 Elanco’s API network activities, provide QA related expertise in compliance with regulatory and GMP requirements
-Participate as QA API function in Elanco’s launch project to ensure the timely launch of new products implementing new APIs and API sources according to the registered set-up.
-Evaluate and support the remediation of any quality related issue and non-conformity at an Elanco external API partner and drive continuous improvement initiatives.
-Drive the utilization of Risk Management principles for API CMOs/Suppliers oversight and monitor API CMOs/Suppliers QA performance metrics and reports.
-Master’s Degree or higher in chemistry or pharmacy or a related discipline is required.
-5 years of GMP experience in the quality control, quality assurance or production of the API or pharmaceutical industry with high focus on analytical chemistry.
-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.
-Technical and scientific writing and documentation capabilities meeting the standard of Health Authority reviewers.
-Demonstrated problem solving, quality risk management and decision making skills within the regulated environment of the API or pharmaceutical industry.
Travel: 10 – 20%