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Boehringer Ingelheim

Associate Director, Biostatistics and Data Sciences - Quality Management

Post Date:Feb 14, 2018Type:Full-Time
Start Date:2/13/2018Salary:
Location:US-CT-Ridgefield Job Reference:US*234_1712207
Skills:
 

Job Description:

Description:

This position can be located one of five locations\:  Ridgefield, CT, Ingelheim Germany, Biberach, Germany, Tokyo, Japan or Shanghai, China.


Description\:

This position, known as the Global BDS Quality Information Manager (gBDS-QIM), is responsible for globally managing and analyzing information from multiple sources as a basis for oversight and control of quality critical processes in gBDS.  This includes but is not limited to analyzing, generating and distributing aggregeated quality information related to compliance or knowledge management.  This position also supports implementation of Quality Management principles (Quality by Design, Qualitative Risk Management, and Quality Management System) in BDS globally. 

The role communicates and collaborates closely with the BDS Quality Management leadership team by analyzing data, identifying potential quality and governance issues, and evaluating options to address the issues, but will also involve frequent communicate with senior leadership of BDS.  Overall, the position will provide business value by combining information from different sources (e.g., LOS, GEM, IDEA4CON, IDEA4GEN) in innovative ways and is responsible to deliver quality related insights about processes, interfaces or different parts of the BDS organization (e.g., CROs, vendors).

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\:

  • Manage and analyze information from multiple sources to develop and communicate trends on global and regional levels to provide insights to the BDS quality strategy and ensure oversight and control of quality critical processes in BDS.

  • Continuously manage and improve quality tracking, monitoring and reporting of quality issues for BDS.  Provide metrics based on CAPA management KPIs, internal KQIs, and knowledge assets.  Provide analysis and interpretation of trends to management on performance to enhance BDS quality strategy.

  • Take the lead on content development of the BDS Quality Newsletter, by collating learnings from non-compliances and audit findings and consulting with Global Process Owners, BDS Training Committee members, BDS Quality Management on other relevant quality topics to be shared with the BDS community via the Newsletter.

  • Support BDS Quality Management in quality-related meetings to bring forward quality issues for discussion (e.g., CAPA Leads meeting, Training Committee meeting)

  • Ensure gBDS materials in Knowledge Management system are maintained according to the gBDS strategy through oversight.  Liaise with the gBDS Training Committee, Global Process Owners, SOP authors as necessary.

Requirements\:

  • Bachelor’s degree from an accredited institution in a scientific/technical field is required. 

  • At least five (5) years of proven experience in an analytical position in either a life-science, health industry or pharmaceutical industry. 

  • Ability to work independently as well as in a team.   

  • Good/excellent communication and presentation skills are required. 

  • Knowledge of QMS-related systems is preferred.

  • It is important to have strong analytical and technical skills (e.g., Excel, Project, Access, and Shareroom) as well as skills to independently manage multiple tasks simultaneously.

  • A solid knowledge of ICH GCP and/or a knowledge of the areas spanned by biostatistics, data management, statistical programming, and computer application support services used in clinical development and their interfaces among functions within BDS and outside BDS is important. 

  • Ensure compliance with ICH GCP, the company's standards, policies and procedures.

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

Our Culture\:


Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees.  Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.  Since we are privately held, we have the ability to take an innovative, long-term view.   Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families.  Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work.  Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Merial Barceloneta, 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; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.





Contact Information
Boehringer Ingelheim



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