Senior Principal Specialist, QA

Location: North Brunswick Township, NJ (08902)
Company: Boehringer Ingelheim
Industry: IT
Job Type: Full Time
Posted: 4 days ago


The SR Principal Specialist, QA provides support to new product registrations for Boehringer Ingelheim Animal Health. This role implements procedures to ensure the integrity of all BI AH research and development outputs intended for regulatory submissions.

This position will serve as lead QA representative for projects or studies. The incumbent will need to collaborate with other BI QA colleagues for studies or projects to ensure timelines are met. At other times, the position will work independently. External to QA, this position requires good communication skills both written and verbal to communicate issues observed.

This position is complex. The incumbent is required to work in a multi-regulated environment while balancing competing priorities while helping ensure that work generated globally is conducted per regulatory requirements and company procedures. This may interface with project teams, Industrial Operations, other BI groups, and BI support functions.

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 several 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\:

  • Provides QA support to new product registrations for BI AH GI.
  • Acts as QA representative in GI projects and ensures its GMP compliance.
  • Reviews and approves CMC documentation in the suitable systems (MDG, BIRDS, ) to ensure consistency between development output and regulatory submission dossier.
  • Supports the QA release of GMP Products and raw materials based on current legislation and valid external and internal guidelines to ensure successful market authorization applications.
  • Manages and leads the program of supplier qualifications to ensure quality compliance with international regulations (GxPs) and BI quality standards for all third parties used at NBRC.
  • Acts as the Local Management System Owner for the entire GI organization or NBRC for Quality Systems as necessary and assigned.
  • Aligns the process with the Divisional Management System Owner and if necessary, with the Global Management System Owner.
  • Identifies opportunities for quality improvements and gains approval for and implementing quality improvements.


  • BA/BS in chemistry, life sciences, pharmacy, or a related field.
  • More than 8 years prior QA experience in GLP, GMP, GCP or other GxP areas Prior experience in the pharmaceutical, biological industry or equivalent.
  • Ability to work in a project team environment and independently.
  • Strong oral and written communication skills.
  • Interpersonal skills.
  • Ability to manage conflict.
  • Strong computer skills (MS Word, Excel, and PowerPoint)
  • Expert in interpretation and practical application of applicable regulations and guidelines (GxP, FDA, EPA, OECD, USDA).

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 here 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 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.

Web Reference : AJF/358828724-202
Posted Date : Thu, 30 Jun 2022

Please note, to apply for this position you will complete an application form on another website provided by or on behalf of Boehringer Ingelheim. Any external website and application process is not under the control or responsibility of IT JobServe

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