US
0 suggestions are available, use up and down arrow to navigate them
What job do you want?

Associate Director / SR Associate Director, Quality & Compliance – Deviation job in Saint Joseph at Boehringer Ingelheim

Create Job Alert.

Get similar jobs sent to your email

List of Jobs

Apply to this job.
Think you're the perfect candidate?
Associate Director / SR Associate Director, Quality & Compliance – Deviation at Boehringer Ingelheim

Associate Director / SR Associate Director, Quality & Compliance – Deviation

Boehringer Ingelheim Saint Joseph, MO Full-Time

Description:

Description\:

The basic purpose of this position is to provide technical direction and serve as a subject matter expert (SME) for product disposition activities to assure that Quality systems and processes are in place.  Also, be an SME for the documentation of the deviation, root cause analysis, CAPA, and impact assessment of the event.  Responsible for implementing procedures to assure compliance with EU, USDA, and corporate requirements; and ensuring final investigation reports meet regulatory and BIAH requirements.  This position will indirectly support the Quality and Compliance department according to company policies and corporate business plans and to provide technical support to QA Release functions.  Participate and helps lead regulatory inspection.  This position also serves as a deputy (backup) to the Director in the event of their absence.

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\:

  • Responsible for tracking and reporting status of all action items on a routine basis to assure Quality systems are in place to support the business across sites during company acquisitions and divestures.

  • Assures all site processes are in place to support the business.  Review and approve laboratory and manufacturing investigations to ensure compliance with BIVI policies and applicable regulatory guidance.  Coordinate investigations across all functions within operations, ensure effective root cause analysis, and develop corrective and preventive actions for associated events relating to biological production operations and associated quality systems. Ensure timely completion of investigations per procedures and the implementation and completion of corrective and preventive actions.

  • Training\:

  • Completes all assigned training by target due dates as assigned by BIVI.

  • Assists in development of training plans and trains others, including training outside of area of responsibility.

  • Assists as needed in development and maintenance of training curricula.

  • Indirectly supports the following Quality & Compliance activities as needed\:

  • Deviations/CAPA

  • Change Control

  • Regulatory Activities

  • QA management activities, including staffing, budget, compensation, KPIs, strategic planning.

  • Audits/Inspections

  • May have Management Responsibilities to include\:

  • Manages department expenses.

  • Communicates staffing expectations to applicable QA staff.

  • Develops assigned direct reports. t

  • Identifies equipment/tools needed for QA Release.

  • Provides input for performance reviews and compensation approvals. 

  • Performs data generation & provides reports/updates for Quality Management reviews

  • Performs business and strategic planning for area of responsibility in alignment with Company objectives

Requirements\:

  • Bachelor's degree from an accredited institution in a scientific discipline or relevant field. 

  • A minimum of ten (10) years of strategic experience in QA systems and processes including deviation management within in a GMP regulated manufacturing facility or similar environment.  Experience must be inclusive of six (6) years leading people, projects and leaders. 

  • Preferred regulatory experience in FDA and/or EU regulated environment. 

  • Sterile product manufacturing experience preferred.

  • Must be able to handle multi tasks and provide the leadership to implement solutions to complex problems using the best available technology.

  • Change management experience is critical for this position, including successful leadership of organizational transformation within relevant QA functions.

  • Demonstrated ability to use technical knowledge to solve problems. 

  • Proficiency in relevant computer software and programs associated with the organization to detail and commitment to customer service.

  • Requires the ability to utilize computer programs such as Microsoft suite, GoTrack, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.

  • Demonstrated high ethical and professional standards with all business contacts in order to maintain BI AH’s excellent reputation in the community.

  • Basic understanding of EU GMPs, Outlines of Production, 9 CFR and compliance requirements is required for this position in order to properly assess product, procedures, recommend/drive improvements and make correct decisions.

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

  • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click [ Link removed ] - Click here to apply to Associate Director / SR Associate Director, Quality & Compliance – Deviation for more information on the vaccine mandate and COVID-19.

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.

RSRBI

Recommended Skills

  • Auditing
  • Biology
  • Change Control
  • Change Management
  • Corporate Laws
  • Corrective And Preventive Action (Capa)
Apply to this job.
Think you're the perfect candidate?

Help us improve CareerBuilder by providing feedback about this job:

Job ID: AR02-5950_223189

CareerBuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.