> Markdown version of [/jobs/ext/1417095-us_us-quality-manager-external-api](https://www.wearedevelopers.com/jobs/ext/1417095-us_us-quality-manager-external-api). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # US_US Quality Manager External API - **Company:** Boehringer Ingelheim - **Location:** Columbus, OH, United States - **Contract:** Permanent contract - **Skills:** Application Programming Interfaces (APIs), Api Management - **Published:** July 24, 2026 - **Apply:** https://dejobs.org/x/x/AD6CD40699B14AB3B34721C29BD651EA/job/ ## About the Role * Bachelors Degree in Chemistry, Pharmacy or applicable Physical Science * Comprehensive knowledge of international GMP standards, global regulatory requirements, pharmacopoeia requirements, and applicable compliance procedures. * In-depth expertise in pharmaceutical analysis, quality assurance, and API manufacturing operations. * Extensive experience in cross-functional and cross-country collaboration and proven ability to work effectively across interfaces, including coordination and project management in complex environments. * Proven capability to lead and influence complex matrix teams is essential, along with strong people management skills such as educating, motivating, coaching, and empowering teams and workgroups. * Results-oriented mindset, an integrative personality, and strong team collaboration skills are required, supported by intercultural awareness and sensitivity. * Solid management and Business Process Excellence (BPE) competencies and the ability to manage high levels of complexity arising from multiple sites, products, and country-specific requirements. * High degree of initiative, flexibility, and assertiveness is expected. * Very good written and spoken English skills are required. Eligibility Requirements : * Must be legally authorized to work in the United States without restriction. * Must be willing to take a drug test and post-offer physical (if required). * Must be 18 years of age or older. ## Description The Quality Manager, External API Management is responsible for quality oversight of externally sourced APIs used at BI sites and external CMOs., * Providing quality oversight for externally sourced APIs in compliance with international cGMP standards and BI corporate regulations. * Supporting supplier selection and overseeing quality aspects of API supplier management. * Maintaining overall quality responsibility for assigned API's and API suppliers. * Leading and supporting lifecycle management activities, including product and/or analytical transfers, and representing Quality Assurance in cross-functional transfer project teams for both New Chemical Entities (NCEs) and established products. * Escalating potential quality events, proposing solutions to the Quality Governance Structure, and leading global quality decision-making processes. * Developing and implementing quality system standards across internal and external (local and global) interfaces. * Driving the development, implementation, and monitoring of Quality Assurance Agreements (QAAs) This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site., * Provides oversight, interpretation, and implementation of requirements and regulatory guidelines for externally sourced API's. * Coordinates quality activities for defined API lifecycle projects (including supplier qualification). * Represents Quality Control and Quality Assurance in global governance and operational forums, serving as the quality focal point for external API-related topics. * Prepares and presents key quality performance indicators (KPI's) to support global visibility of API quality performance. * Proactively communicates the status of critical quality activities and issues. * Contributes to Product Management Reviews (PMR) by representing API-related topics within the Product Quality Overview (PQO). * Authorized to make quality-related decisions within the scope of responsibility. * Serving as the Quality Representative on matrix teams supporting supplier selection for externally sourced APIs. * Conducting and supporting API supplier assessments. * Representing Quality in Business Review Meetings (BRMs). * Owning and updating Quality Assurance Agreements (QAAs). * Managing and overseeing change control activities across the API lifecycle. * Closely collaborating with Quality units at BI API-producing sites, the virtual plant for externally sourced APIs, and downstream pharmaceutical manufacturing "customers" and their Quality functions. * Leading global cross-functional teams, as needed, to drive informed, timely decisions on quality matters throughout the product lifecycle. * Leading Quality related projects to ensure regulatory compliance as required. ## Related Videos - [Rest API Antipatterns](https://www.wearedevelopers.com/videos/100208-rest-api-antipatterns) - [From APIs to MCP: Enterprise Governance, Registry, and Controls](https://www.wearedevelopers.com/videos/100336-from-apis-to-mcp-enterprise-governance-registry-and-controls) - [An Opinionated Guide to Bulletproof APIs](https://www.wearedevelopers.com/videos/100182-an-opinionated-guide-to-bulletproof-apis) - [Web APIs you might not know about](https://www.wearedevelopers.com/videos/281-web-apis-you-might-not-know-about) - [Say goodbye to building boring APIs with Azure Data API Builder](https://www.wearedevelopers.com/videos/1194-say-goodbye-to-building-boring-apis-with-azure-data-api-builder) - [Why make use of an integration platform in today's software developments and infrastructure?](https://www.wearedevelopers.com/videos/758-why-make-use-of-an-integration-platform-in-today-s-software-developments-and-infrastructure) ## Related Articles - [Jobs in Germany for Americans](https://www.wearedevelopers.com/magazine/423-jobs-in-germany-for-americans) - [Starter Kit For Job Applications For Developers](https://www.wearedevelopers.com/magazine/7-starter-kit-for-job-applications-for-developers) - [Finding Jobs in Germany](https://www.wearedevelopers.com/magazine/375-finding-jobs-in-germany) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023) - [Best Companies to Work For in Berlin: Top 14 Companies in 2023 ](https://www.wearedevelopers.com/magazine/188-best-companies-to-work-for-in-berlin-top-14-companies-in-2023) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies)