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Principal Specialist, QA Auditing (Remote)

Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: June 12, 2021

Job Description:

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 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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

'621397

Keywords: Boehringer Ingelheim, Saint Joseph , Principal Specialist, QA Auditing (Remote), Other , Saint Joseph, Missouri

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