Associate Director, Quality Assurance
Company: Boehringer Ingelheim
Location: Athens
Posted on: March 20, 2023
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Job Description:
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.
Description:
The Associate Director, Quality Assurance is responsible for
ensuring compliance of site manufacturing processes according to
cGMP regulations. Also responsible for implementing, maintaining,
and monitoring all Quality processes necessary for that assurance.
This includes leading skilled people, running the operations
according to cGMP regulations, and identifying and implementing
business process improvements and that will drive business
performance and Quality innovation. Incumbent provides technical
expertise on Quality standards and processes to team members;
provides strategic direction on specific departmental operations
and implements tactical planning within the department for daily
operations. Responsible for major organizational Quality function
such as Deviations, Quality Agreements, Validation Oversight or
Change Controls.
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:
Plans, directs and manages the work of assigned Quality group(s);
provides technical leadership to corrective and preventive action
(CAPA), deviation and change controls as necessary to ensure each
project within the group is completed in accordance with
departmental mission. Establishes department mission
statements.
Provides oversight for the development of project budgets and
monitors expenditures. Optimizes allocated department resources.
Works with clients, suppliers, contracted organizations and other
BI sites as necessary to achieve goals.
Proposes and executes process and procedural changes to improve
process performance, robustness, productivity and efficiency.
Applies metrics to departmental mission to drive continuous
improvement.
Collaborates functionally and cross-functionally to implement
Quality strategy and objectives. Performs both independently and in
team settings. Works closely with department Director to set and
implement goals.
Serves as Leader for new initiatives relating to department.
Removes barriers to successful implementation and works to resolve
them.
Requirements:
Bachelor's degree from an accredited institution, preferably in
Life Sciences, Engineering or similar pursuit, required.
8 years of experience working in the Quality aspects of life
sciences or closely related industry, required.
5 years of management and/or leadership experience, including
experience managing within complex matrix organizations and
projects, required.
Must have demonstrated ability to execute against the strategic and
tactical objectives provided by senior leaders both within Quality
and outside of the function.
Requires strong collaboration, negotiation and ability to in a team
environment and collaborate with peers.
Overall understanding of Quality Systems and processes within a
pharmaceutical / biopharmaceutical manufacturing organization
Prior experience budgeting and financial forecasting highly
desired.
Must have demonstrated abilities in goal setting, team leadership,
staff coaching and development and communication.
Strong understanding and appreciation for regulatory requirements
and quality and compliance standards under which the Fremont site
is operating.
Physical Demands / Surroundings - Works primarily in an office
setting under desirable conditions with few or no disagreeable
features. Duties do not require incumbent to exert physical effort
beyond normal office conditions. The individual may be required to
enter and perform work in the manufacturing areas. This may include
periods of frequent standing or working. Some domestic and
international travel required.
Visual Demands - Must be able to read and see clearly. Vision
clarity with or without correction to read handwritten as well as
computer generated documents.
Attendance / Schedule - Attendance requirements are based on
general attendance policies and the needs of the business as set
forth by direct manager.
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.
Organization: US-Boehringer Ingelheim Animal Health
Title: Associate Director, Quality Assurance
Location: Americas-US-GA-Athens
Requisition ID: 231044
Keywords: Boehringer Ingelheim, Athens , Associate Director, Quality Assurance, Executive , Athens, Georgia
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