Principal Specialist, QA Auditing (Remote)
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: June 12, 2021
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
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
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
- 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
- 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
- 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
- Enable global quality overview of BI suppliers, challenge their
status and identify gaps/risks for BI's Supply Chain
Work environment includes on site auditing of key suppliers.
Incumbent must make evaluations of existing systems.
- Must apply a wide array of complex regulatory requirements,
SOP's, Contractual terms, and company policies in a tactful,
- Highly regulated and complex regulatory landscape(USDA,FDA,DEA,
- 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
- 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
- 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
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- 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.
Keywords: Boehringer Ingelheim, Saint Joseph , Principal Specialist, QA Auditing (Remote), Other , Saint Joseph, Missouri
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