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Associate Director- Site Quality Assurance

Morristown, NJ

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Your tasks and responsibilities The primary responsibilities of this role, AssociateDirector Site Quality Assurance, are to:u00a0 Lead the implementation, maintenance and continuousimprovement of the Bayer Consumer Health Innovation&Development (I&D) Good Manufacturing Practices (GMP) QualityManagement System including the creation/revision/review of QualitySystem Documents (QSDs), local administration of change management,timely completion of deviations and investigations, implementationof corrective and preventive measures, compilation of qualitymetrics etc.; Oversee document control/archiving processes whilemaintaining an awareness of current GMP trends and regulatoryauthority expectations; Direct the activities to ensure facilities,equipment and processes are qualified, calibrated and operatedconsistent with current GMPs; Who you are Oversee the review and disposition of rawmaterials, stability/product batches and consumer study andclinical trial materials etc. in compliance with internal standardsand GMP regulations; Review data and documentation for GMP activitiessuch as registration stability, analytical protocols and reports(validation, transfer), specifications, batch documentation,Certificates of Analyses, etc.; Represent GMP Quality on I&D projectteams; Provide input into development strategies tosupport innovation, achieve business objectives and maintain GMPcompliance; Escalate quality issues to the Head of GlobalI&D Quality in a timely manner; Work with the other development sites to maintainsite metrics, preparing trend analysis, recommending correctiveactions and learning across sites; Represent I&D site Quality Assurance (QA) ininternal audits and regulatory inspections; Ensure that responses to auditobservations/inspection findings (internal and external) arecompleted in a satisfactory and timely manner; Exhibit professionalism and foster teamwork tocreate an environment of support that leads to productivity ofI&D personnel and ensures GMP compliance. WHO YOU ARE Your success will be driven by your demonstration ofour LIFE values. More specifically related to this position,Bayer seeks an incumbent who possesses thefollowing: Required Qualifications: Minimum of a Bachelor's Degree in QualityAssurance, Chemistry or related science; At least ten yearsu2019 experience in a GoodPractices (GxP) regulated industry; At least seven years of experience in R&DQuality Assurance; Thorough knowledge of GMPs and product developmentprocesses; Ability to work cooperatively in teams and peerrelationships; Ability to effectively manage multiple, complex andchanging priorities; Excellent communication skills and good influencingskills. Preferred Qualifications: Experience with Consumer HealthProducts.

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