Quality Manager, External APIs - Hybrid Role

Boehringer Ingelheim; Columbus (OH); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim in Columbus, Ohio is seeking a Quality Manager, External API Management to oversee externally sourced APIs across BI sites and CMOs. The role emphasizes cGMP compliance, supplier qualification, and cross-functional collaboration.

You will lead lifecycle activities for NCEs and established products, drive QAAs, and implement QA standards across internal and external interfaces while maintaining quality governance. Hybrid on-site 2-3 days.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy or applicable Physical Science.
• Extensive knowledge of international GMP standards and regulatory requirements.
• Experience in quality assurance and API manufacturing operations.
• Ability to lead cross-functional matrix teams and manage projects.
• Strong English communication skills.

Responsibilities

• Provide quality oversight for externally sourced APIs in compliance with cGMP standards.
• Support API supplier qualification and quality aspects of supplier management.
• Maintain overall quality responsibility for assigned APIs and suppliers.
• Lead lifecycle management activities including transfers and QA involvement.
• Escalate quality events and drive global quality decisions.
• Develop and implement quality system standards across interfaces.
• Manage QAAs and oversee API change control.

Skills

GMP knowledge

Quality Assurance

API lifecycle management

Cross-functional leadership

Project management

Leadership of matrix teams

English proficiency

Education

Bachelor's degree in Chemistry, Pharmacy or applicable Physical Science

Job description

Boehringer Ingelheim in Columbus, Ohio is seeking a Quality Manager, External API Management to oversee externally sourced APIs across BI sites and CMOs. The role emphasizes cGMP compliance, supplier qualification, and cross-functional collaboration.

You will lead lifecycle activities for NCEs and established products, drive QAAs, and implement QA standards across internal and external interfaces while maintaining quality governance. Hybrid on-site 2-3 days.