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Group Leader, Quality & Comp-Devn

Company: CTI Education Group
Location: Saint Joseph
Posted on: February 22, 2021

Job Description:

Job Description - Group Leader, Quality & Comp-Devn (2015404) Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities. Group Leader, Quality & Comp-Devn - 2015404 Description: Responsible for leadingthe day to day operations of the group pertaining to investigation ofdeviations, and the subsequent documentation of the deviation, root causeanalysis, CAPA, and impact assessment of the event.Responsible for implementing procedures toassure compliance with EU, USDA, and corporate requirements; and ensuring finalinvestigation reports meet regulatory and BIAH requirements. 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:

  • Coordinates theoverall operation of the group. Prioritizes work, resolves issues, develops andinstitutes quality and efficiency improvements, and conducts performancereviews.Maintains key performanceindicators for operational investigations.
  • Maintains personalknowledge skills in the awareness of current regulatory and corporatepractices.
  • Review and approvelaboratory and manufacturing investigations to ensure compliance with BIAH policies and applicable regulatory guidance.Coordinate investigations across all functions within operations,ensureeffective root cause analysis, and develop corrective and preventive actionsfor associated events relating to biological production operations andassociated quality systems. Ensure timely completion of investigations perprocedures, and the implementation and completion of corrective and preventiveactions.
  • Training:
  • Completes all assigned training by target duedates as assigned by BIAH.
  • Assists indevelopment of training plans and trains others, including training outside ofarea of responsibility.
  • Assists as needed in development andmaintenance of training curricula and qualifications.
  • Demonstrate high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation in the community. Requirements:
    • Four (4) year degreefrom an accredited institution in a scientific discipline
    • Minimum eight (8)years of experience in regulated industry
    • Well versed inregulatory requirements
    • Ability toeffectively manage people.
    • Effectiveinterpersonal skills with a diverse group of individuals at all organizationallevels
    • Ability to evaluateand interpret data and formulate logical and sound conclusions andrecommendations
    • Ability to usetechnical knowledge to solve problems
    • Proficiency inrelevant computer software and programs associated with area.
    • Excellent writtenand verbal communication skills
    • Attention to detailand commitment to customer service
    • An understanding ofbiological manufacturing, regulatory requirements, as well as goodcommunication and strong writing skills are required to perform and documentthe investigations. Well versed in regulatory requirements
    • Requires the abilityto utilize computer programs such as Microsoft suite, GoTrack, SAP, IDEA forCON, Learning One Source and other relevant electronic applications.
    • A basicunderstanding of EU GMPs, Outlines of Production, 9 CFR and compliancerequirements is required for this position in order to properly assess product,procedures, recommend/drive improvements and make correct decisions. Eligibility Requirements:
      • 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. 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 receiveconsideration for employment without regard to race; color; creed; religion;national origin; age; ancestry; citizenship status, marital, domesticpartnership or civil union status; gender, gender identity or expression;affectional or sexual orientation; pregnancy, childbirth or related medicalcondition; physical or psychiatric disability; veteran or military status;domestic violence victim status; genetic information (including the refusal tosubmit to genetic testing) or any other characteristic protected by applicablefederal, state or local law.

Keywords: CTI Education Group, Saint Joseph , Group Leader, Quality & Comp-Devn, Other , Saint Joseph, Missouri

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