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Manager, QA Auditing

Boehringer Ingelheim

This is a Full-time position in Fulton, MO posted May 2, 2021.


Description: Provides support andcompliance expertise in GCP and bioanalytical guidelines and GLP regulationsfor new BI product registrations. Implements procedures to ensure integrity of BI research output intendedfor regulatory submission. Monitors and contributes to facility processessupporting GLP, GCP and Bioanalytical studies. Provide leadership andmanagement support to QA personnel on site in alignment with functionalmanagement expectations. As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers. Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies’ success. We realize that our strength and competitive advantagelie with our people. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion, mobility,networking and work-life balance. Our competitive compensation and benefitprograms reflect Boehringer Ingelheim’s high regard for our employees. Duties &Responsibilities:Manage, assign andexecute facility inspections, critical phase audits, in-process GCP audits anddata and report audits to support BI Clinical OperationsConduct and assignsaudits and critical phase inspections of BI and contract facilities to ensureadherence to BI quality requirements and regulatory directives.Audit assignedprotocols, study data and reports for compliance with U.S. and E.U. regulations(FDA, EPA, VICH, OECD). Ensure the studiesare conducted and the data are collected in compliance with the protocol,applicable guidelines, procedures, and other governing factors.Audit R&Ddepartments for compliance to regulatory directives, divisional anddepartmental policies and procedures. Review R&Dprocedures for compliance with regulatory directives and BIAH qualitystandards.Work with ProjectTeams to meet timelines associated with auditing/reviewing raw data or reports.Confer withInvestigators, Monitors and QC or clinical management regarding quality orregulatory practices or issues relative to clinical studies.Host regulatoryinspections at local site (MRC) and veterinarian clinical west of theMississippi river.Identifyopportunities for quality improvements, gain approval for and assist indeveloping systems for implementing quality improvements. Provide timely andaccurate reporting of quality performance measures to customer departmentsProvide and delegatetraining to MRC, QA, BI and CRO personnel in GLP or GCP principles.  Requirements:Five (5) years’experience in conducting regulatory and quality audits in the pharmaceuticalindustry.Practical knowledgeand/or experience in how animal clinical trials are conductedThe incumbentpossesses specific and detailed process knowledge regarding a particularR&D process (e.g. analytical, hematology, PV, pathology, clinicalmonitoring, sterile manufacturing, validation, etc.). The incumbent isable to communicate effectively and autonomously with a wide variety ofexternal/internal customers.The incumbent mustbe able to work autonomously and make quality decisions with minimalsupervision.Knowledge of EPA,FDA and OECD GLP regulations and guidelines, VICH GL9 Good Clinical Practiceguideline and their practical application in R&D processesis required.Strong oral andwritten communication skills and interpersonal skills are required.Ability to work in aproject or team environment.Fluency in MS Wordand Excel software is required.Understandapplication of the GLP regulations, GCP guidelines and industries GoodDocumentation Practice to facility processes, study programs and submissions;bioanalytical guideline to bioanalytical analysis and method validations. Analyticalbackground/experience to evaluate analytical sets and recommend correctiveactions in support of submissions. Experience todevelop and train QA auditors as well as site and CRO personnel.RegulatoryRequirements:FDA 21 CFR Part 511,New Animal Drugs for Investigational Use (NAD)FDA 21 CFR Part 514,New Animal Drug Applications (NADA)ENV/MC/CHEM(98)17 -Organisation for Economic Co-operation and Development (GLP)FDA 21 CFR Part 58 –Good Laboratory Practice (GLP)EPA 21 CFR Part 160– Good Laboratory Practice (GLP)FDA guidancedocuments:FDA Guidance forIndustry – Bioanalytical Method ValidationCVM Guidance forIndustry No. 85 – Good Clinical Practices, VICH GL 9CVM Guidance forIndustry No. 185 – Target Animal Safety for Veterinary Pharmaceutical Products,VICH GL 43BIORESEARCHMONITORING GOOD LABORATORY PRACTICE Compliance Program 7348.808 (NonclinicalLaboratories)FDA Program Policyand Procedures Manual 1243.8220 – BIMO Inspection Request Process (ClinicalInvestigators) EligibilityRequirements:Must be legallyauthorized to work in the United States without restriction.Must be willing totake a drug test and post-offer physical (if required)Must be 18 years ofage or older Who We Are:At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance. We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture. Learning and development forall employees is key because your growth is our growth. Want to learn more? andjoin us in our effort to make more health. BoehringerIngelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., BoehringerIngelheim USA, Boehringer Ingelheim Animal Health USA Inc., BoehringerIngelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont,Inc. is an equal opportunity and affirmative action employer committed toa culturally diverse workforce. All qualified applicants will receive considerationfor employment without regard to race; color; creed; religion; national origin;age; ancestry; citizenship status, marital, domestic partnership or civil unionstatus; gender, gender identity or expression; affectional or sexualorientation; pregnancy, childbirth or related medical condition; physical orpsychiatric disability; veteran or military status; domestic violence victimstatus; genetic information (including the refusal to submit to genetictesting) or any other characteristic protected by applicable federal, state orlocal law.  

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