At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Global System Auditor
The Global System Auditor plays a significant role in the ability of Bayer Pharma (BPH) and Bayer Consumer Health (BCH) to operate as a business by significantly influencing how all product development processes meet the expectations in terms of regulatory compliance and efficiency/productivity at a global level. This is achieved through the following activities:
YOUR TASKS AND RESPONSIBILITIES
- Manage audit team to ensure timely completion of Global System Audit activities by design and approval of detailed system audit plans for country and process audits in the area of R&D, Medical Affairs, Pharmacovigilance, and Commercial
- Develop relevant audit tools for collection of audit data, conduct and reporting of audits including identification of improvement areas, communication of system audit results within Bayer Pharma and Bayer Consumer Health as well as follow-up of audits including assessment of corrective/preventive actions
- Prepare, conduct, report, and follow-up of document audits (e.g. software validation documentation, submission documents, Pharmacovigilance relevant documentation)
- Provide interpretation and guidance for internal and external customers on R&D, Medical Affairs, Pharmacovigilance, and Commercial quality related regulations/guidelines (FDA, ICH, EU, GVP etc.) and company procedures and policies, proactively maintaining cognizance of current applicable standards
- Support the development and refinement of the Global Quality System by participating in SOP authorship or review teams
- Support of regulatory authority inspection activities as needed with focus on R&D, Medical Affairs, Pharmacovigilance, and Commercial topics
WHO YOU ARE
University Degree (B.Sc. or M.Sc.) in a biomedical science or equivalent education
- Several years of working experience in the pharmaceutical industry
- Several years of experience of product development related activities and a proven record in Research & Development / Medical Affairs / Pharmacovigilance / Commercial auditing activities
- Ability to assimilate large amounts of data efficiently, exercise sound judgement, and maintain composure to effectively handle sensitive issues
- Professionalism, strong stakeholder management, and ability to develop interdepartemental relationship
- Strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results
- Oral and written proficiency in the English language
- Willingness to travel up to 40% and to accommodate time zone differences in case of remote audits
We offer some flexibility on the location. This role could be either based in our Basel office or home based if you live in Switzerland or in our other global locations in UK or USA.
We are looking forward to receiving your application by 30th September Thank you!
Sie suchen eine Herausforderung, in der Sie Ihre Leidenschaft für Innovationen einbringen können? Sie möchten Teil eines globalen Teams werden und gemeinsam mit uns das Leben auf der Welt verbessern? Dann bewerben Sie sich online mit Ihren vollständigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse).
Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht. Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.