Job description

Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Quality Manager, External API Management is responsible for quality oversight of externally sourced APIs used at BI sites and external CMOs. Key responsibilities include: • 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. Duties & Responsibilities • 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. Requirements • 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.

Requirements

Must-haves

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.
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)
Duties & Responsibilities
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.
Bachelors Degree in Chemistry, Pharmacy or applicable Physical Science

Nice-to-haves

None flagged.

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Keywords to mirror

api

Platform: successfactors
Effort: medium