YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Process and Compliance Manager, are to: 

• Be accountable for global compliance for Plant Biotechnology, interprets complex regulations and coordinates company-wide response for compliance for traits (e.g. Latin America permitting);
• Ensure availability, maintain and further develop processes and tools to keep the business compliant with requirements of internal and external R&D Quality processes, partners and authorities;
• Assess the possible quality risks of processes, tools, documents etc.;
• Set and apply state of the art R&D quality measures;
• Communicate relevant changes in policy or process with various levels of leadership;
• Support training to relevant employees across the global organization;
• Develop program to train and track compliance of external providers for Plant Biotechnology;
• Develop and ensure auditing to compliance and quality policies;
• Interpret, create, manage and support agency permits for Plant Biotech R&D;
• Be accountable to Regulatory Science to understand permit conditions and assess compliance feasibility;
• Guide and support the development of Standard Operating Procedures (SOP);
• Ensure appropriate containment measures are in place to meet permit conditions and ensure no material is out of place;
• Identify novel solutions and process improvement initiatives;
• Lead change using quality philosophies such as TQM, Lean and Six Sigma Address compliance incidents, perform root cause analysis and proactively mitigate process risks;
• Ensure trait quality policies and procedures are followed and manages trait quality incidents for plant biotechnology.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree with at least seven years of relevant experience or Master’s degree with at least five years of relevant experience or Ph.D. in scientific field with at least three years relevant experience;
• Experience with regulatory agency compliance, plant breeding and/or molecular laboratory environment;
• Experience with Compliance and/or Trait Quality;
• Good knowledge of R&D business practices and processes;
• Project Management skills;
• Strong interpersonal and communication skills with ability to challenge status quo;
• Understanding of Regulatory processes such as permits, confined trials and laboratory compliance, and quality systems such as ISO 9001:2015;
• Project management experience with the ability to drive projects to completion while working under tight timelines;
• Excellent oral and written communication skills;
• Ability to work in a matrix environment, leading and influencing people at varying levels of responsibility;
• Ability to excel in ambiguous and complex environment;
• Thinking objectively and leveraging information to develop corporate strategies and guidelines that effectively balances compliance and operations;
• Proficient in Bayer’s enterprise data management and analysis software;
• Experience leading IT strategies and building solutions to meet changing business needs;
• Experience with LEAN philosophies and/or Six Sigma methodologies.

Domestic relocation may be available for this role.