Director Quality Consultant

• 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.

• Director Quality Consultant

• YOUR TASKS AND RESPONSIBILITIES

• The primary responsibilities of this role, Director Quality Consultant, are: + Act as SAM subject matter expert in R D-related topics regarding quality risk management and mitigating measures, monitoring and identifying trends, keeping current and advising on industry topics (e.

g. on new regulations related to clinical trials: e.g. risk based monitoring / auditing, data protection, ethics in clinical trials, pediatric clinical development, interrelation between GxPsetc.), R D business processes as well as innovative audit methodology and technology. + Represent Bayer at industry associations (e.g.

VFA, ICQA, EF-GCP, RQA, SQA

etc.) with the purpose of steering interpretation and implementation of new regulations, e.g. on Clinical trials, data privacy, ethics in clinical trials, pediatric clinical development within SAM, monitoring and maintaining knowledge on quality intelligence, regulations, and benchmarking with other companies in the field of GCP auditing. + Lead strategic projects and initiatives, steer global expert working groups, develop concepts and oversee roll-out and implementation into practice. + Act as independent, mature and highly professional trusted advisor, and global SAM representative + Review and analyze trends, develop strategic mitigation plans and act as quality consultant on process improvements for R D including providing information on the effectiveness of risk-mitigation actions in order to facilitate improvements. + Drive the interaction with procurement and business process owners, in the management of strategic suppliers and take initiative for supplier oversight measures including feedback on supplier audit performance and resulting measures. + Main representative for Quality Talk consultancy content + Represent SAM, as assigned, in risk management workshops and Study Start-up camps in coordination with SALs, PRPs, and Quality Strategists and provide the possible study quality risk factors to the teams in these workshops. + Self-Assessment Coordination and Lead Auditee in SAM Self-Assessments + Representative of Bayer R DQ with co-development partner and strategic supplier agreements. + Analyse global audit and inspection trends and deliver the content of QA Training topics to Medical Directors, Clinical Operations (incl ODO) Leads, and regional compliance managers. + Act as senior GCP consultant, for cross functional QSD expert working groups + Collaborate externally and internally in the following activities: + a. To analyze internal and external quality challenges, customers`requirements, and resources to develop plans to achieve R DQ - SAM'sshort and long-term objectives, in the most efficient and effective way, sustaining quality improvement and innovation, and building and maintaining a sophisticated quality mindset. + b. Contribute to and review of Quality Metrics (e.g.

KPI / OQR/QMRR

) +

Senior Global Clinical Auditor:

+ Conduct, on a global level, GCP audits of suppliers, clinical study sites, clinical study oversight, and document audits to assess compliance with the clinical investigation plan, ICH GCP Guidelines, applicable regulatory requirements, and current and established company procedures. This will include investigation with, and constructive feedback to, Principal Investigators/ Key Opinion Leaders and senior representative of the Bayer PH organizarion. + Provide interpretation and guidance for internal and external customers on clinical quality related regulations/guidelines (FDA, ICH,EU, etc.) and applying company procedures and policies, proactively maintaining cognizance of current GCP standards. This often involves sponsorship of issues for global Quality Management consensus or acting as the primary GCP consultant for quality system document expert working groups + Manage clinical study site and supplier audit activities for key studies and projects. This will include managing complex, important, or multiple projects on a global level: interact with product development teams (in particular, the

GCL, GCPM

) to identify and characterize new clinical studies as potential candidates for audit, proactively advise the study team and GCL of any significant quality issues arising from the audit program; for individual studies interact with study managers to develop and refine audit plans; interact with the Regional Head, SAM to ensure agreement, tracking, and fulfillment of the audit plan; develop audit tools; review draft audit reports; and communicate any quality trends to the study team. This also includes representing Health Authority Inspections globally (during preparation, conduct and follow-up). + Maintain study and supplier audit plans providing support to the auditors performing the audits, conducting the peer review process of the audit reports, analyzing the results of the audits, detecting areas of risks and improvement opportunities to be discussed with the clinical team in compliance with the current applicable company procedures. + Train and mentor less experienced auditors.

• WHO YOU ARE

• Bayer seeks an incumbent who possesses the following:

• Required Qualifications:

• + Bachelors degree: + Pharmaceutical industry experience in Quality Management and/or Clinical Research, and experience in Clinical Quality Assurance.

In-depth knowledge, experience and expertise in the application of good clinical practice (GCP) requirements is required (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to clinical studies. + The incumbent should be familiar with medical terminology and routine medical tests and procedures. + Confident and adept in the use of computerized databases and other applications including familiarity with computerized clinical data collection systems. + Excellent knowledge of Bayer's business, organization and underlying processes + Strong credibility with Bayer colleagues based on prior success in global role(s), honed by experience with senior management interaction + Proven leadership (motivational and interpersonal) skills and project management skills, in highly visible projects with strong team building ability, effective planning and organizational skills, attention to detail, excellent follow through, as well as excellent negotiating and influencing skills + The incumbent must possess people management skills in order to effectively and independently manage teams assigned to the projects under his/her leadership + Proven analytical, conceptual, innovative and strategic skills + Oral and written communication skills with proficiency in English are necessary + Professionalism is mandatory as the incumbent must interact directly with all levels of Bayer staff up to and including Sr. Vice President level and with Principal lnvestigators/Key Opinion Leaders, providers of services to Bayer, GCLs, CPM`s, OPLs, Medical Directors, Heads of Site Operations and others. The ability to develop interdepartmental relationships is critical. + Incumbent must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues. + The incumbent must be aware of the key differences in how business is practiced various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship and effectively represent Bayer as a multinational corporation. + This position involves approximately 30% regional and global travel.

Preferred Qualifications:

+ Bachelors degree with at least 8 years (or an MS with at least 7 years) of pharmaceutical industry experience in Quality Management and/or Clinical Research, of which at least 5 years should be in an accomplished Clinical Quality Assurance role. In-depth knowledge, experience and expertise in the application of good clinical practice (GCP) requirements is required (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to clinical studies. Employees can expect to be paid a salary of between $150,400.00 - $225,600.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least: 4/23/2026.

• YOUR APPLICATION

• Bayer offers a wide variety of competitive compensation and benefits programs.

If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies:

Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement:

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Visitors:

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• Location:

•

United States :

Residence Based :

Residence Based

• Division:

• Pharmaceuticals

• Reference Code:

• 865620
• Contact Us

• Email:

• hrop_usa@bayer.

com