About SpringWorks Therapeutics

SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.

About the Role:

The Senior Quality Systems Training Specialist who will be responsible for supporting the Quality Assurance (QA) Training Manager in completion of site training objectives and goals. Provides assistance in the identification and development of training content. Primary contact for external customers to identify, develop, plan, implement, and project manage system improvements. Create, assign, and maintain curricula at the enterprise level to support GxP and non-GxP areas of the business.

Responsibilities Include:

  • Liaison between functional groups and provide recommendations on how training content should be delivered in SpringWorks Learning Management System (LMS) (i.e. classroom, SCORM Read and Understand).
  • Set up classroom training and quiz design in SpringWorks LMS.
  • Responsible for the day-to-day operations of the learning management system.
  • Provide efficient and timely customer service, ensuring relevant documentation is processed appropriately.
  • Partner with functional areas to implement training to support commercial operations (i.e. Healthcare compliance and Privacy training initiatives).
  • Assist QA Training Manager with the review of training materials and training records, to support Quality Governance.
  • Lead annual curriculum audit review and provide guidance to department leaders.
  • Support regulatory inspections and internal audits.
  • Assist in the management of electronic records in Veeva Quality Docs and Veeva Training
  • Support additional quality systems including audits.
  • Deliver site GDP training and ongoing site refreshers.
  • Provide reporting and updates on training metrics and training completions.
  • Work with HR business partners to ensure required courses and policies are delivered in our Veeva system.
  • Monitor and evaluate training program effectiveness.
  • Support the Training Manager in the writing, auditing, and updating content in the EDMS.
  • Perform other duties and responsibilities as assigned.

About You: Required Education, Skills, and Experience

  • Education: Bachelors Degree
  • 7+ years of experience in biotechnology or pharmaceutical industry
  • Must have a working knowledge Learning Management System (Veeva or similar).
  • E-Learning/Instructional Design
  • Strong Technical Writing Skills to develop and implement SOPs and Work Instructions
  • Prior experience leading or managing a training program within a regulated environment.
  • Strong oral and written communication skills.
  • Excellent interpersonal, teamwork, and organizational skills to work across collaboratively globally.
  • Proficiency with Microsoft products and document publishing software (e.g. Excel and Adobe Pro); must be able to learn additional applications as needed.
  • Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities
  • Regularly interacts with cross functional personnel on matters concerning several functional areas. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship or the goals of the organization
  • Ability to lead and to interact and influence as an individual contributor.
  • This position must be able to work East Coast hours
  • Ability to travel occasionally (>15%)

Are you a SpringWorker?

How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?

At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients.   We work hard, we care even harder and we’re in it together.  We are looking for ambitious, smart, and hardworking colleagues to join our growing team.                                  

SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.

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Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.

Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

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