Manager/Senior Manager, GxP Training

Full-TimeEidosSan Francisco, CAQuality Assurance

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About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are:

The primary role of the Manager/Senior Manager, GxP Training will be to manage the development, implementation, and sustainability of quality and technical training programs. This position will ensure employees and contract staff meet compliance requirements relating to knowledge, skill, and practices necessary for their job performance and remain prepared to perform assigned tasks. This position reports to the Sr. Director, QA.
Responsibilities:
  • Develop and execute GxP Training strategy
  • Work directly with all levels and departments at Eidos to establish training curriculums and assignments based on assigned functions
  • Evaluate GxP training needs and participate in developing and delivering training materials, utilizing high-quality, innovative, timely, and effective learning solutions
  • Process and maintain file system for training records
  • Improve current learning management processes and end-user experience
  • Work with Document Control and other functional departments to coordinate training on new or revised procedures
  • Provide guidance and information to leadership on recommended training programs, curricula and training material development, and learning assignments
  • Support inspections and audits
  • Build and run training compliance metrics
  • Manage projects and training initiatives that directly support GxP initiatives to implement strategic business objectives in driving quality and compliance effectively

  • No matter your role at BridgeBio, successful team members are:
  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements:
  • BS/MS degree
  • Minimum 7 years of relevant experience with GxP Training
  • Biotech/pharmaceutical/GxP industry or expertise in a highly regulated environment is strongly preferred
  • Extensive knowledge of SOPs and GxPs and the know-how to work and manage within a regulated environment
  • Strong change management skills and demonstrated ability to simplify and improve business processes
  • Adaptable to a fast-paced, complex, and ever-changing business environment
  • Solid verbal and written communications skills
  • Strong organizational skills and attention to detail
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
  • Experience with eLMS is preferred
What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Manager/Senior Manager, GxP Training

Full-TimeEidosSan Francisco, CAQuality Assurance

Apply Now