Boehringer Ingelheim is hiring a

Senior Corporate Quality Manager / Quality Audits & Inspections

Biberach, Germany

The Position

As a Senior Corporate Quality Auditor within our Global Quality Audits and Inspection (QAI) group, you will play a pivotal role in ensuring GxP compliance across Boehringer Ingelheim's worldwide Human Pharma and Animal Health networks. Through internal and external audits, you will verify adherence to regulatory requirements, company standards, and industry best practices, contributing to the continuous improvement of our Quality Management System. Located in Germany, this position offers the opportunity to leverage your expertise in quality management, auditing and modern data analytics to drive excellence in pharmaceutical development, manufacturing and commercialization.

This position can be filled in Ingelheim or Biberach.

Tasks & responsibilities

As part of your role, you will schedule, prepare, conduct and report on Global Quality Audits for Boehringer Ingelheim sites, global functions and processes as well as Contract Manufacturing Organizations (CMOs), including regular, for-cause, and mock-PAI audits.
By assessing the implementation of Boehringer Ingelheim’s quality and GxP standards, you will help to ensure compliance with regulatory requirements and proactively address potential quality risks.
Identifying, communicating and escalating compliance issues or significant risks uncovered during audits will be a key aspect of your role. It will be your responsibility to ensure an adequate CAPA plan is established at the site after the audit and that checks for effectively implemented CAPAs will be done during the next audit.
Keeping a close eye on industry trends and regulatory agency interpretations of GxP requirements will enable you to provide valuable insights and guidance. Staying up-to-date with evolving global GxP standards will allow you to maintain and enhance your expertise in the field.
Where required, you will also take the lead or contribute to project teams focused on improving Boehringer Ingelheim’s compliance with regulatory requirements.
Additionally, you will define and maintain specific components of Boehringer Ingelheim’s Quality Audit and Inspection System, ensuring its continuous improvement and alignment with best practices.

Requirements

Bachelor’s, Master’s, or Doctoral degree (e.g. PhD, MD) with a focus on Pharmaceutics, Biopharmaceutics, Engineering, or Science
Long term practical experience in GMP-regulated environments (e.g. Quality Control, Manufacturing, Engineering, Drug Development), including experience in Quality Assuranceor regulatory compliance management
Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations, along with exposure to authority inspections (FDA, EMA, USDA or other international health authorities)
Experience in working within matrix organizations and demonstrated audit skills with appropriate qualifications
Ability to identify and resolve GxP-related issues while adhering to company and regulatory standards as well as proficiency in data analytics, including AI
Strategic and conceptual thinking, cross-functional and cross-country collaboration, and the ability to drive compliance initiatives and programs are key capabilities
English proficiency including excellent written and oral communication skills (German or French language skills will be of advantage)
The ability to frequently travel (up to 50 %) is a pre-requisite for this role

Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process:

Step 1: Online application - The job posting is presumably online until April 27th, 2026.
Step 2: Virtual meeting in the period from end of April until beginning of May
Step 3: On-site interviews beginning mid of May

Please submit your application documents in English.

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