Director, Quality and Compliance
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: November 12, 2019
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
- Strategic BusinessResponsibilities\: Establishes strategic
quality and compliance initiatives fordevelopment and production of
- 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
- 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
- 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
- Shares expertise ina state of the art vaccine manufacturing
- Ensures thatschedules, plans, equipment and resources are
deployed to optimize cost,quality, delivery and compliance
- 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.??
- Bachelors degreefrom an accredited institution with a minimum
of ten (10) years progressiveexperience and a broad range of
experience and technical competence inveterinary/vaccine
- 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
- Must possess a working knowledge of all business disciplines to
ensureability to ?partner? with all functional departments of the
- 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
- Demonstrated versatility in conflict resolutions, problem
solving, andworking effectively as a part of a cross functional
- 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
- Must be legallyauthorized to work in the United States without
- Must be willing totake a drug test and post-offer physical (if
- 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??
Visitboehringer-ingelheim.com 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
Didn't find what you're looking for? Search again!