Principal GCP Auditor / GCP Auditor

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
The Position
As an Auditor in our Corporate Department Quality Medicine (QM), you will perform Good Clinical Practice (GCP) related audits in the areas of Clinical Development & Operations, Translational Medicine, Biostatistics and Data Management worldwide. In more detail, this includes process audits, system audits, at BI Operating Units and audits at investigator sites, as well as audits at CROs and other service providers.
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 please use this link: Associate Director, Global QM Auditor (boehringer-ingelheim.com) / 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 & responsibilities
In your role as a Global QM Auditor, you will have the opportunity to:
  • Lead the way in planning and conducting risk-based audits across various functional areas, showcasing your expertise as a Lead Auditor.
  • Utilize your keen analytical skills to identify potential risk areas and provide insightful assessments on the impact of audited activities.
  • Play a pivotal role in coordinating audits performed by external auditors, ensuring seamless preparation and overseeing the audit results for maximum effectiveness.
  • Collaborate closely with our dedicated compliance team to review audit responses, fostering a strong partnership for success.
  • Act as a trusted advisor to our business functions, offering valuable guidance on quality standards and driving continuous improvement.
  • Embrace the concept of quality by design and actively contribute to the enhancement of our auditing process, making a lasting impact on our organization.
  • Prepare for and actively participate in regulatory inspections, demonstrating your commitment to upholding the highest standards of quality and compliance.
As a Global Principal QM Auditor, you will take on even more challenging and rewarding tasks, including:
  • Showcase your exceptional auditing skills by preparing, conducting, and reporting on complex routine and sensitive for-cause audits (both internal and external) as a lead auditor. Ensure compliance with procedural documents, maintain high-quality standards, and meet assigned timelines as directed by QM auditing management.
  • Stand out as a subject matter expert in specific auditing areas, leading projects within the auditing function and/or cross-functionally with confidence and independence.
Requirements
  • A Bachelor’s degree in medicine, pharmacy, life science, or a related field is required, with a Master’s degree or equivalent being preferred.
  • Several years of experience in auditing or a senior advisory role in quality management, or extensive professional experience in a relevant function within the pharmaceutical industry.
  • Deep understanding of GCP regulations and legal requirements, coupled with advanced analytical and problem-solving skills to comprehend and simplify complex issues.
  • Excellent communication skills in English, both verbal and written, with proficiency in computer skills. Knowledge of German would be a plus.
  • Strong interpersonal skills with an open-minded and reliable personality, capable of independent and team work. Must be willing to travel (inter)nationally up to 50% of the time.
Additional Requirements for the Global Principal Auditor:
  • Demonstrate global strategic thinking and expertise in Medicine-related regulations and processes, ensuring compliance and excellence in all areas.
  • Excel in ad-hoc decision-making within a highly regulated environment, showcasing your adaptability and critical thinking skills.
  • Utilize your advanced project management and leadership experience to drive success and innovation in auditing and/or quality management.
  • Exhibit exceptional intercultural communication, internal consulting, and change management skills, fostering collaboration and growth within the organization.
Internal Job Title: Global QM Auditor / Global Principal QM Auditor
Fixed term contract: no
Part time eligible: no
Organizational unit: Corp. Div. Medicine / Global Quality Medicine/ Global Auditing / Global GCP Auditing Group I
Start date: 1 January, 2024
Apply until: 20.12.2023
Salary range: VG3 Business (Auditor) / VG2 Business (Principal Auditor). This target can be achieved if requirements and personal aspects are fulfilled. We welcome applications from people with disabilities.
Internal job offers are generally addressed to employees working in their current position for at least one year or working on a fixed term contract ending within one year.
For employees with a current contract of limited duration, legal / labor agreement requirements for contract extension will be considered.
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 Jan 31st,2024.
Step 2: Virtual meeting in the period from beginning of February, 2024.
Step 3: On-site or virtual panel interviews beginning of end of February 2024.
Recruiter: Désirée Altenhofen
Hiring Manager: Bianca Krampf

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Boehringer Ingelheim
Boehringer Ingelheim

Current Openings: 0

Seit mehr als 135 Jahren erforscht, entwickelt und produziert Boehringer Ingelheim neue Medikamente mit hohem therapeutischem Nutzen für Mensch und Tier. Als Pharmaunternehmen in Familienbesitz planen wir langfristig und investieren daher besonders in die Forschung und Entwicklung. Wir sind stolz, so einige der größten Gesundheitsprobleme unserer Zeit angehen zu können. Unsere Vision „Werte schaffen durch Innovation“ hat unsere Zusammenarbeit seit jeher geprägt und ist für uns Anspruch und Antrieb zugleich. Mit Hauptsitz in Ingelheim, Deutschland, beschäftigt Boehringer Ingelheim weltweit insgesamt rund 53.000 Mitarbeiter. Weitere Informationen zu Boehringer Ingelheim finden Sie unter www.boehringer-ingelheim.de
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