Boehringer Ingelheim

Senior Corporate Quality Manager – Quality Audits, Inspections

Boehringer Ingelheim

full-time

Posted on:

Location Type: Office

Location: Ingelheim • Germany

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Job Level

Senior

About the role

  • 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, ensuring compliance with regulatory requirements and proactively addressing potential quality risks.
  • Identify, communicate and escalate compliance issues or significant risks uncovered during audits.
  • Ensure an adequate CAPA plan is established at the site after the audit, checking for effectively implemented CAPAs 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 to maintain and enhance expertise in the field.
  • Lead or contribute to project teams focused on improving Boehringer Ingelheim’s compliance with regulatory requirements.
  • 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, 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.
Benefits
  • Applications from persons with severe disabilities are warmly welcomed.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPGxPISOCSVdata analyticsaudit skillsCAPAregulatory compliancequality assurancePharmaceutics
Soft Skills
strategic thinkingconceptual thinkingcross-functional collaborationcross-country collaborationcommunication skillsproblem-solvingleadershipteamworkinitiativeadaptability
Certifications
Bachelor's degreeMaster's degreeDoctoral degreePhDMD