Associate Director/Director, Quality Assurance

Full-TimeEidosSan Francisco, CAQuality Assurance

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Eidos Therapeutics, a subsidiary 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in the US (San Francisco, Palo Alto, Boston, New York, Raleigh), and EMEA (Zug, Switzerland) with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.bridgebio.com

Who You Are:

The Associate Director/Director, Quality Assurance is responsible for executing and managing the GCP Compliance program at Eidos and assigned BridgeBio affiliates. It requires strong judgment skills and business acumen to advise internal and external critical stakeholders on interpretation and compliance with international regulations/guidelines, corporate policies, and standard operating procedures (SOPs).  This individual will be an active participant and critical point of contact in the management of regulatory inspections.
Responsibilities:
  • Support the internal and external audit program; manage audit processes/procedures and supervise audit assignments; lead and/or participate in audit activities as needed
  • Communicate critical information regarding the significant quality or patient safety risk to Executive Management and key stakeholder
  • Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
  • Assist the organization with developing and continuously improving processes and systems
  • Assist with developing and managing quality documents, including SOPs
  • Support the training program, including issuing and tracking training
  • Manage and assist with regulatory inspections globally and oversee the development and tracking of regulatory commitments
  • Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed
Education, Experience & Skills Requirements:
  • Bachelor’s degree with 12+ years of relevant Quality experience within a biopharmaceutical company or contract research organization; direct industry experience in lieu of education will be considered
  • Current knowledge of global GxP regulations 
  • Ability to engage in cross-functional interactions with internal and external staff
  • Excellent verbal and written communications skills, with a strong customer focus
  • Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways
  • Develops technical and/or business solutions to complex problems
  • Identifies and applies advanced practices, technical principles, theories, and/or concepts and contributes to the development of new regulations and concepts
  • Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos’ programs
  • Applies strong analytical and business communication skills
What We Offer:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Associate Director/Director, Quality Assurance

Full-TimeEidosSan Francisco, CAQuality Assurance

Apply Now