• Job Description

  Req#: 234363
  Description:
  
  As an Auditor in our Corporate Department Quality Medicine (QM), you will perform Good Clinical Practice (GCP) audits mainly in the areas of biostatistics, clinical data management and computer systems validation (CSV) worldwide. In more detail, this includes process audits, system audits, audits at Boehringer Ingelheim Operating Units, as well as at external partners, e.g. software service providers, CRO's and other service providers.
  
  Prepare, conduct and report to auditees and management routine audits as a lead or co-auditor and for-cause audits as a co-auditor in compliance with the procedural documents in good quality and within timelines and as assigned by QM audit management and ensure thereby a compliant execution of the QM global annual audit program.
  
  Identify areas of risk and provide independent assessments on impact of audited activities and processes on patient safety, patient rights and data integrity and on compliance with internal and external regulation.
  
  Oversee assigned specific product portfolio and/or functional areas within QM auditing and proactively drive continuous improvement of the global auditing strategy and process in liaison with the respective line manager.
  
  This position may require minimally 40% international travel for conducting audits.
  
  As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
  
  Duties & Responsibilities:
  
  • Provide our business functions with QA and guidance on biostatistics, clinical data management as well as on CSV.
  • Prepare global internal and external audits (all audit types including process, systems, partner and supplier audits) as assigned and liaise with relevant stakeholders including Audit Operations Analysts to focus on significant areas to be audited. Preparation includes planning and strategy of individual audits with development of appropriate audit scope.
  • Conduct audits as lead or co-auditor as assigned on site or remotely as appropriate and planned.
  • Coordinate input of global SMEs during the audit.
  • Report audits in compliance with timelines described in the QM auditing process and in good quality.
  • Coordinate audits performed by external auditors, facilitate preparation when necessary and oversee audit results.
  • Review global audit reports from the QM global auditing team as peer-reviewer to ensure accuracy in terms of coding and criticality assessment, regulatory references and format.
  • Liaise closely with the compliance team in development of auditing responses by reviewing audit responses to ensure accuracy.
  • Oversee assigned specific product portfolio and/or functional areas within QM auditing and manage independently trending and analysis activities as required.
  • Participate actively and drive continuous improvement of the global auditing strategy and - process within cross-functional projects in liaison with the respective line manager.
  • Create proactive and continuous inspection readiness for assigned projects, prepare and manage regulatory inspection by representing the auditing function and contributing to inspection activities as needed.
  
  Compensation: This position offers a base salary typically between $120,000 and $248,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
  
  Requirements SAD Level:
  
  • Bachelor's degree from an accredited institution in life science or other disciplines related to Quality or comparable qualification.
  • Master's degree or higher preferred.
  • At least eight (8) years of experience in auditing and/or experience in a senior advisory role in quality management and/or at least twelve (12) years of professional experience in the pharmaceutical industry in a relevant Medicine function (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics and Data Management, computer system validation).
  • Comprehensive knowledge and GCP or GxP experience in the pharmaceutical industry that is relevant to the area(s) of responsible auditing.
  • Intercultural communication, internal consulting and change management skills.
  • Lead and work well in teams or independently.
  • Ability to influence and negotiate.
  • Strong organizational and prioritization skills with efficient and effective time management.
  • Good analytical and problem-solving skills.
  • Excellent oral and written communications skills in English language.
  • In depth knowledge of GxP regulatory requirements.
  • In depth knowledge of all Medicine relevant regulations and processes in HPBU and IU.
  
  
  Requirements AD Level:
  
  • Bachelor's degree from an accredited institution in life science or other disciplines related to Quality or comparable qualification.
  • Master's degree or higher preferred.
  • At least six (6) years of experience in auditing and/or experience in a senior advisory role in quality management and/or at least ten (10) years of professional experience in the pharmaceutical industry in a relevant Medicine function (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics and Data Management, computer system validation).
  • Comprehensive knowledge and GCP or GxP experience in the pharmaceutical industry that is relevant to the area(s) of responsible auditing.
  • Intercultural communication, internal consulting and change management skills.
  • Lead and work well in teams or independently.
  • Ability to influence and negotiate.
  • Strong organizational and prioritization skills with efficient and effective time management.
  • Good analytical and problem solving skills.
  • Excellent oral and written communications skills in English language.
  • In depth knowledge of all Medicine relevant regulations and processes in HPBU and IU.
  
  Eligibility Requirements:
  
  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.
  • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
  
  Who We Are:
  
  At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
  
  Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
  
  Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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