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.
- Schedule, plan, andprepare for external supplier and contractor audits on behalf of BIpharmaceutical world functions, including Operations, Development, Biopharmaand Animal Health, as well as internal audits of BIAH and other BI operatingunits Operations, Development, Biopharma and Animal Health divisions.
- Lead and conductaudits of external suppliers and contractors on behalf of the BIAH facilitiesand external suppliers and contractors on behalf of the BI manufacturing world,including Operations, Development, Biopharma, and Animal Health.
- Prioritize and self-manageaudit and inspection tasks.
- Create and issue theaudit report for each audit to submit to BIAH management as a means to ensureSOP(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-upactions and oversee investigations of compliance issues noted during audits andinspections or otherwise observed or reported.
- Perform follow-upactions, including over-site of compliance issues noted during audits andinspections or otherwise observed or reported.
- Plan, perform,document, and conduct required post-audit activities for assigned internal andexternal audits to ensure timely closure of CAPAs.
- Communicatedeviations from the cGMP or other Regulations observed duringaudits/inspections, recommend appropriate corrective action when necessary, andverify that appropriate corrective actions have been implemented that adequatelyaddress any deviations reported during audits to BI Quality Management.
- Resolve qualityconcerns and implement quality improvements by meeting with other departmentManagers, Staff Managers to assure current methods, procedures or SOP’s meetcurrent standards. Develop, review and/or approve documents associated withSupplier Quality Management (e.g., change controls, specifications, compliancecertificates, etc.).
- Mentor and trainother BI auditors regarding auditing skills, and current and future quality andregulatory trends as part of BI global supplier auditor training.
- Serve as the subjectmatter expert to suppliers on compliance topics for BIAH.
- Acts as a resourcefor colleagues (especially USA and EU)regarding Good Manufacturing Practice(GMP) for APIs, excipients and Good Distribution Practice, and pharmaceuticalproducts (GDP).
- Enable globalquality overview of BI suppliers, challenge their status and identifygaps/risks for BI's Supply Chain Integrity.
- Work environmentincludes on site auditing of key suppliers.Incumbent must make evaluations of existing systems.
- Must apply a widearray of complex regulatory requirements, SOP's, Contractual terms, and companypolicies in a tactful, assertive manner.
- Highly regulated andcomplex regulatory landscape(USDA,FDA,DEA, EMEA).
- Significanttechnical/operational risk due to increasing legal, regulatory and biologicalcomplexity.
- Vaccine productionsite for animals, including those used as a human food source.
- May also participatein audits of human pharmaceutical development and production facilities
- Preparesproduct-related quality documents requiring a high level of technical,regulatory and organizational knowledge.
- Work is self-directed.
- Guidance andfeedback can impact regulatory compliance and ability to do business.
- Effectiveness ofquality function assures no interruption of product supply due to regulatory nonconformance
- Working knowledge ofscientific methods and regulatory requirements used to manufacture, test,evaluate, and distribute biological and pharmaceutical products critical toability to function in role
- Matrix reportingstructure: Direct (solid line) reporting structure with Manager, QualityAuditing and indirect (dotted line) reporting structure with Manager, GlobalQuality Auditing.
- Matrix reportingstructure:
- Direct (solid line)reporting structure with Manager, Quality Auditing and indirect (dotted line)reporting structure with Manager, Global Quality Auditing.
- Must be able to passa background investigation, including verification of past employment, criminalhistory, and educational background
- Physical Demands /Surroundings:
- Lifting – 25 poundsoccasionally
- Carrying 25 poundsoccasionally
- May require extendedperiods of sitting, walking standing
- Climb stairs,bending/stooping, crouching/squatting occasionally
- Writing frequently
- May have periods ofuse of Personal Protective Equipment
- Visual / HearingDemands:
- Contact lenses areallowable.
- May require extendedhours at a computer screen.
- Must be able to readelectronic documents of all types.
- 70% travel required
- 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 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
join us in our effort to make more health.
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.