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Director, Quality and Compliance

Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: November 12, 2019

Job Description:

Description:Description\:?Provide strategicleadership and oversight of the site's Quality & Compliance for vaccinemanufacturing and global product distribution within the areas of QualityAssurance (QA), Quality Control (QC), and Veterinary Quality Services(VQS).? Ensure Quality operationalexcellence initiatives lead to sustainable processes that increase robustnessand improve efficiencies.? Responsiblefor Strategic planning, direction and leadership for all compliance related GXPtraining (cGMP).? Responsible forstrategic planning, direction and leadership for supporting auditing ofvendors(ACE), local contract manufacturers, internal audits and regulatoryinspections for the site.? Providesstrategic direction, leadership and oversight to all Quality & Compliancefunctional areas including, but not limited to, Validation (process, equipment,cleaning and systems validation), Quality Control, Quality Assurance, ComputerSystem Validation, and Compliance for all products distributed globally withinapplicable US site(s). Provides leadership and direction to site Operationsrelated to implementing quality policies, strategic plans, systems andprocedures that will assure purity, efficacy, safety and potency of allproducts manufactured or tested at the site.?Provides technical leadership to various departments including, but notlimited to, Commercial Operations, Marketing, Product Development, RegulatoryAffairs, and R&D for quality issues relating to current products, productlaunch, as well as ensuring the facilities registered /approved for worldwideproduction/distribution.? Serves as afocal point for regulatory inspections pertaining to, but not limited to, FDA,USDA, European Union, Russian, Canada authorities, Japan and MCA. Ensures compliancewith all regulatory requirements relating to product quality by implementationof cGMPs and through education and training of the workforce.? Responsible for final regulatory approval ofthe site for all product categories for the following\: testing, inspection andrelease of packaging components, raw materials, labeling, and finishedproducts; product and process validation; quality documentation; contactmanufacturing quality activities; and execution of release of export products,recalls, market withdrawals.??? Thisposition may serve as a deputy for the Executive Director, Operations for inhis/her absence.?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\:

  • Strategic BusinessResponsibilities\: Establishes strategic quality and compliance initiatives fordevelopment and production of global products.
  • Strategic QualityDevelopment\: As Part of site leadership team provides input into strategicobjectives and direction for improvement to the operations team.
  • Complianceresponsibilities\: Functions as a liaison between Global QA/InternationalRegulatory Affairs for technical compliance issues pertaining to products soldin the USA and in other countries worldwide.
  • Responsible for resolving all product quality complaints and adverseevents for products.
  • Responsible for regulatory inspections such as FDA, USDA, EU, JMAFF, Russia,MCA, Canadian and Australian authorities.
  • Training, Development & Performance Management Functions\: Directsoperations training on cGMPs, 9CFR, 22CFR Part11, EU GMPs.? Set direction and provide leadership for costeffective compliance initiatives. Responsible for succession and developmentplans of employees within the Quality organization.? Performance management accountabilities.
  • Validation responsibilities\: Provides leadership and direction to setpolicies and procedures in place to meet strategic company goals forDevelopment and Production.
  • Quality Assurance & Quality Control\: Provides leadership anddirection to pharmaceutical and biological functions relating to budget, vendorcertifications, specification development, stability testing, release ofcomponents, raw materials and products.??
  • Networks withCorporate and Global Functions to influence, understand, and translaterequirements for assigned site from manufacturing perspective.
  • Shares expertise ina state of the art vaccine manufacturing facility.
  • Ensures thatschedules, plans, equipment and resources are deployed to optimize cost,quality, delivery and compliance requirements.
  • Ensures compliance with all regulatory, quality and environmental, healthand safety, requirements for vaccine manufacturing and production maintenancefunctions. Accountable for ensuring that all manufacturing equipment is availablefor use and performing within all applicable regulatory requirements.?? ?Requirements\:
    • Bachelors degreefrom an accredited institution with a minimum of ten (10) years progressiveexperience and a broad range of experience and technical competence inveterinary/vaccine production.
    • Six Sigma or Lean manufacturing practices required.
    • Ten (10) or moreyears of Leadership experience
    • Five (5) years ofexperience working with business process excellence concepts such as Lean?
    • Must demonstrate proficiency in applicable global regulatory requirementsincluding EU, cGMP, 9CFR.?
    • Experience working collaboratively in a matrix environment ispreferred.?
    • Must possess a working knowledge of all business disciplines to ensureability to ?partner? with all functional departments of the organization.?
    • Must exercise rapid learning ability, attention to detail, excellentcomputer skills, excellent communication skills, team player, organizedanalytical thinker with a high level of energy and self-motivation, excellentwriting skills.??
    • Ability to develop and maintain strong working relationships withinternal and external; global and regional; regulatory and governing bodies.
    • Demonstrated versatility in conflict resolutions, problem solving, andworking effectively as a part of a cross functional team.
    • Strategic leaderwith influence to impact/improve processes in support of the business.?Desired Skills,Experience and Abilities\:
      • Six Sigma Green belt desired.
      • Strong scientific and technical background and experience in all areas inthe Biotech and Pharmaceutical industry desired.?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.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.

Keywords: Boehringer Ingelheim, Saint Joseph , Director, Quality and Compliance, Executive , Saint Joseph, Missouri

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