Principal Specialist, QA Auditing
US-Boehringer Ingelheim Animal Health
 MO (Missouri)

Description:

Leads and conducts

external audits to assess the quality / compliance of current Good

Manufacturing Practice (cGMP), applicable regulations, and applicable company

policies and procedures of external suppliers and contractors on behalf of the

BIAH facilities and external suppliers and contractors on behalf of the BI

manufacturing world, including Operations, Development, Biopharma, and Animal

Health. Ensures corrective measures are

implemented. Provides transparency of risks from non-compliance. Assesses the

implementation and execution of quality / GMP standards at suppliers and

contractors to meet FDA/EU and other relevant regulatory requirements, and to

prevent and mitigate quality risks.

As an employee of

Boehringer Ingelheim, you will actively contribute to the discovery,

development and delivery of our products to our patients and customers. Our

global presence provides opportunity for all employees to collaborate

internationally, offering visibility and opportunity to directly contribute to

the companies' success. We realize that our strength and competitive advantage

lie with our people. We support our employees in a number of ways to foster a

healthy working environment, meaningful work, diversity and inclusion,

mobility, networking and work-life balance. Our competitive compensation and

benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties &

Responsibilities:

  • Schedule, plan, and
    prepare for external supplier and contractor audits on behalf of BI
    pharmaceutical world functions, including Operations, Development, Biopharma
    and Animal Health, as well as internal audits of BIAH and other BI operating
    units Operations, Development, Biopharma and Animal Health divisions.
  • Lead and conduct
    audits of external suppliers and contractors on behalf of the BIAH facilities
    and external suppliers and contractors on behalf of the BI manufacturing world,
    including Operations, Development, Biopharma, and Animal Health.
  • Prioritize and self-manage
    audit and inspection tasks.
  • Create and issue the
    audit report for each audit to submit to BIAH management as a means to ensure
    SOP(s), facilities, systems, processes and studies conform to applicable cGMP,
    Good Laboratory Practices (FDA, USDA, EU), Good Clinical Practices (FDA),
    and/or Guidance Documents (FDA, USDA,
    EU) internally and for external
  • Perform follow-up
    actions and oversee investigations of compliance issues noted during audits and
    inspections or otherwise observed or reported.
  • Perform follow-up
    actions, including over-site of compliance issues noted during audits and
    inspections or otherwise observed or reported.
  • Plan, perform,
    document, and conduct required post-audit activities for assigned internal and
    external audits to ensure timely closure of CAPAs.
  • Communicate
    deviations from the cGMP or other Regulations observed during
    audits/inspections, recommend appropriate corrective action when necessary, and
    verify that appropriate corrective actions have been implemented that adequately
    address any deviations reported during audits to BI Quality Management.
  • Resolve quality
    concerns and implement quality improvements by meeting with other department
    Managers, Staff Managers to assure current methods, procedures or SOP’s meet
    current standards. Develop, review and/or approve documents associated with
    Supplier Quality Management (e.g., change controls, specifications, compliance
    certificates, etc.).
  • Mentor and train
    other BI auditors regarding auditing skills, and current and future quality and
    regulatory trends as part of BI global supplier auditor training.
  • Serve as the subject
    matter expert to suppliers on compliance topics for BIAH.
  • Acts as a resource
    for colleagues (especially USA and EU)regarding Good Manufacturing Practice
    (GMP) for APIs, excipients and Good Distribution Practice, and pharmaceutical
    products (GDP).
  • Enable global
    quality overview of BI suppliers, challenge their status and identify
    gaps/risks for BI's Supply Chain Integrity.

Requirements:

  • Scope:
    • Work environment
      includes on site auditing of key suppliers.
      Incumbent must make evaluations of existing systems.
  • Complexity:
    • Must apply a wide
      array of complex regulatory requirements, SOP's, Contractual terms, and company
      policies in a tactful, assertive manner.
    • Highly regulated and
      complex regulatory landscape(USDA,FDA,DEA, EMEA).
    • Significant
      technical/operational risk due to increasing legal, regulatory and biological
      complexity.
    • Vaccine production
      site for animals, including those used as a human food source.
    • May also participate
      in audits of human pharmaceutical development and production facilities
    • Prepares
      product-related quality documents requiring a high level of technical,
      regulatory and organizational knowledge.
    • Work is self-directed.
    • Guidance and
      feedback can impact regulatory compliance and ability to do business.
    • Effectiveness of
      quality function assures no interruption of product supply due to regulatory nonconformance
    • Working knowledge of
      scientific methods and regulatory requirements used to manufacture, test,
      evaluate, and distribute biological and pharmaceutical products critical to
      ability to function in role
    • Matrix reporting
      structure: Direct (solid line) reporting structure with Manager, Quality
      Auditing and indirect (dotted line) reporting structure with Manager, Global
      Quality Auditing.
  • Matrix reporting
    structure:
    • Direct (solid line)
      reporting structure with Manager, Quality Auditing and indirect (dotted line)
      reporting structure with Manager, Global Quality Auditing.
  • Must be able to pass
    a background investigation, including verification of past employment, criminal
    history, and educational background
  • Physical Demands /
    Surroundings:
    • Lifting – 25 pounds
      occasionally
    • Carrying 25 pounds
      occasionally
    • May require extended
      periods of sitting, walking standing
    • Climb stairs,
      bending/stooping, crouching/squatting occasionally
    • Writing frequently
    • May have periods of
      use of Personal Protective Equipment
  • Visual / Hearing
    Demands:
    • Contact lenses are
      allowable.
    • May require extended
      hours at a computer screen.
    • Must be able to read
      electronic documents of all types.
  • 70% travel required

Eligibility

Requirements:

  • Must be legally
    authorized to work in the United States without restriction.
  • Must be willing to
    take a drug test and post-offer physical (if required)
  • Must be 18 years of
    age or older

Who We Are:

At Boehringer Ingelheim we create value through innovation

with one clear goal: to improve the lives of patients. We develop breakthrough

therapies and innovative healthcare solutions in areas of unmet medical need

for both humans and animals. As a family owned company we focus on long term

performance. We are powered by 50.000 employees globally who nurture a

diverse, collaborative and inclusive culture. Learning and development for

all employees is key because your growth is our growth.

Want to learn more? Visit

boehringer-ingelheim.com and

join us in our effort to make more health.

Boehringer

Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer

Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer

Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont,

Inc. is an equal opportunity and affirmative action employer committed to

a culturally diverse workforce. All qualified applicants will receive

consideration for employment without regard to race; color; creed; religion;

national origin; age; ancestry; citizenship status, marital, domestic

partnership or civil union status; gender, gender identity or expression;

affectional or sexual orientation; pregnancy, childbirth or related medical

condition; physical or psychiatric disability; veteran or military status;

domestic violence victim status; genetic information (including the refusal to

submit to genetic testing) or any other characteristic protected by applicable

federal, state or local law.