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Senior corporate quality manager / quality audits & inspections

Biberach an der Riß
Boehringer Ingelheim
Qualitätsmanager
Inserat online seit: 31 März
Beschreibung

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 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. Assess the implementation of Boehringer Ingelheim’s quality and GxP standards to ensure compliance with regulatory requirements and proactively address potential quality risks. Identify, communicate and elevate compliance issues or significant risks uncovered during audits; ensure an adequate CAPA plan is established at the site after the audit and verify effective implementation during the next audit. Keep a close eye on industry trends and regulatory agency interpretations of GxP requirements to provide valuable insights and guidance; stay up‑to‑date with evolving global GxP standards. Take the lead or contribute to project teams focused on improving Boehringer Ingelheim’s compliance with regulatory requirements, where required. 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 Assurance or regulatory compliance management. Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations, with exposure to authority inspections (FDA, EMA, USDA or other international health authorities). Experience 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 and 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. English proficiency with excellent written and oral communication skills (German or French language skills are an advantage). Ability to travel frequently (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 e‑mail: hr.de@boehringer-ingelheim.com. Recruitment process Step 1: Online application – The posting is online until 27 April 2026. Step 2: Virtual meeting in the period from the end of April until the beginning of May. Step 3: On‑site interviews beginning mid‑May. Submit application documents in English. Our Company With us, you can develop your own path in a company with a culture that knows our differences are our strengths—and break new ground in the drive to make millions of lives better. Here, your development is our priority, supporting you to build a career in a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after, as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Why Boehringer Ingelheim? Visit Website to learn more. #J-18808-Ljbffr

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