Global (Principal) QM Auditor

As a Global QM Auditor in our Corporate Department Quality Medicine (QM), you will perform audits covering functional areas within Corporate Division Medicine. You will focus on Medical Affairs, Patient Safety and Pharmacovigilance (PSPV), Regulatory Affairs, and Epidemiology. In more detail, this includes process audits, system audits at BI Operating Units and audits at third parties including service providers and PSPV license partners. The purpose of our Quality Assurance audits is to assess the audited area to ensure that the rights, safety and well-being of patients are protected, and that the integrity of data produced is maintained. You will further contribute to continuous improvement for our auditing strategy and process.
Being part of the global QM organization, you are a competent partner to our business functions in leading them to innovatively deliver high quality outcomes. As we aim for excellence in quality, you will guide them to manage and oversee the quality of their work.
This position can be filled in Germany (Ingelheim or Biberach) or in the US (Ridgefield).
Being part of the global QM organization, you are a competent partner to our business functions in leading them to innovatively deliver high quality outcomes. As we aim for excellence in quality, you will guide them to manage and oversee the quality of their work.
This position can be filled in Germany (Ingelheim or Biberach) or the US (Ridgefield).
If you want to apply for the position in the US please use this link: Senior Associate Director, Global Principal QM Auditor (boehringer-ingelheim.com)
If you want to apply for the position in Germany (Ingelheim or Biberach) click "Apply now".
We kindly ask you to apply for the Boehringer Ingelheim location that is closest to your country of residence.
Tasks and Responsibilities
In your function as a Global QM Auditor you will:

• Plan, conduct and report audits based on a risk-based strategy in the assigned functional areas as lead auditor as well as oversee audits conducted by external auditors.
• Identify areas of risk and provide independent assessments on impact of audited activities.
• Coordinate audits performed by external auditors, facilitate preparation and oversee audit results.
• Review audit responses in close collaboration with the compliance team.
• Provide our business functions with guidance for quality standards as required.
• Understand quality by design and actively contribute to drive the improvement of our auditing process.
• Prepare for and participate in regulatory inspections.
  

Additional Tasks for the Global Principal QM Auditor:
You will

• Prepare, conduct and report complex routine as well as sensitive for-cause audits (internal and external audits) as a lead auditor in compliance with the procedural documents in excellent quality and within timelines and as assigned by QM auditing management.
• Independently act as subject matter expert for specific auditing areas towards external and internal stakeholders and lead projects within the auditing function and/or cross-functionally.
  

Requirements

• Bachelor’s degree in medicine, pharmacy, life science, or any other relevant field. Master’s degree or higher preferred.
• Several years of experience in auditing and/or experience in a senior advisory role in quality management and/or long term professional experience in the pharmaceutical industry in a relevant medicine function (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Epidemiology, Clinical Operations and Development).
• In-depth knowledge of GxP regulations and legal requirements of at least one of the required medicine functions (i.e. GVP, RA, GPP).
• Additional knowledge in GCP requirements is a plus.
• Advanced analytical and problem-solving skills with the ability to understand and break down complex issues to key aspects to comprehensively present audit results to a broad audience.
• Advanced communication skills in English (verbal and in writing) and good computer skills are required; German language skills would be an asset.
• Well-developed interpersonal skills are required. Open-minded and reliable personality, positive and agile strategic thinker being able to work independently as well as in a team.
• Willingness to travel internationally, up to a maximum of 50%.
  

Additional Requirements for the Global Principal Auditor:

• Global strategic thinking in all areas paired with in-depth knowledge of all Medicine relevant regulations and processes in HPBU and IU
• Excellent ad-hoc decision making in a highly regulated regulatory environment
• Advanced project management skills
• In depth experience in at least one additional GxP area
• Several years of experience in auditing and/or quality management or long-term experience in one of the above-mentioned Medicine functions
• Proven experience in leading without authority
• Advanced intercultural communication, internal consulting and change management skills
  

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 per mail: hr.de@boehringer-ingelheim.com
Recruitment process:
Step 1: Online application - application deadline is end of February, 2024
Step 2: Virtual meeting in the period from beginning of March, 2024
Step 3: On-site interviews beginning of April, 2024
Please submit your application documents in English.