Global API Quality Manager - Hybrid (Columbus)

Boehringer Ingelheim GmbH; Columbus (OH); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is seeking a Quality Manager for External API Management to oversee API quality and regulatory compliance across internal BI and external CMOs. The role emphasizes collaboration with QA, QC, and cross-functional teams to drive quality governance on an international scale.

The position is based on-site in Columbus, Ohio with hybrid flexibility, requiring strong leadership, global quality process experience, and a proactive approach to supplier quality and regulatory

Qualifications

• Bachelor’s 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.
• Very good written and spoken English skills are required.

Responsibilities

• Provides quality oversight for externally sourced APIs in compliance with international cGMP standards and BI corporate regulations.
• Supports supplier selection and oversees quality aspects of API supplier management.
• Maintains overall quality responsibility for assigned APIs and API suppliers.
• Leads lifecycle management activities, including transfers, and represents QA in cross-functional transfer project teams for NCEs and established products.
• Escalates potential quality events and leads global quality decision-making processes.

Skills

Quality oversight

GMP compliance

API quality

Cross-functional leadership

Regulatory awareness

Project management

KPI reporting

Education

Bachelor’s degree in chemistry or pharmacy

Tools

QMS

Job description

Boehringer Ingelheim is seeking a Quality Manager for External API Management to oversee API quality and regulatory compliance across internal BI and external CMOs. The role emphasizes collaboration with QA, QC, and cross-functional teams to drive quality governance on an international scale.

The position is based on-site in Columbus, Ohio with hybrid flexibility, requiring strong leadership, global quality process experience, and a proactive approach to supplier quality and regulatory