Senior Associate Director, Global Principal Qm Auditor (Remote)

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).

If you want to apply for the position in the US click "Apply now".
If you want to apply for the position in Germany (Ingelheim or Biberach) use this link: Principal GCP Auditor / GCP Auditor (boehringer-ingelheim.com)
We kindly ask you to apply for the Boehringer Ingelheim location that is closest to your country of residence.

• Upon applying for this position, you will encounter a query regarding the visibility of your profile - whether it should be confined to the recruiters managing the jobs you apply to, or be accessible to any company recruiter worldwide. Given that the hiring manager is not based in the country you are applying for, we kindly urge you to opt for "Any company recruiter worldwide". This action will greatly assist us in processing your application in the most efficient manner, while ensuring compliance with the General Data Protection Regulation.

Duties & 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.
• 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 40%.

Compensation