Manager, QA Compliance

Eidos San Francisco, CA/Hybrid Quality Assurance

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About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-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 investigational product, acoramidis (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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, 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 Manager of QA Compliance provides audit and compliance oversight at BridgeBio Affiliates (Cardiorenal, ML BIO, and other affiliates) and contract manufacturing, testing, research, and/or laboratory organizations. This position reports to the Director of QA Compliance. 

Responsibilities

  • Participate in vendor qualification; review and evaluation of contract manufacturing, testing, research, and/or laboratory facilities 
  • Work with cross-functional team to draft audit schedule and ensure internal and vendor audits are performed as per the audit schedule
  • Ensure all audits are followed up and corrective actions are completed, implemented, and verified 
  • Update and maintain approved vendor lists
  • Collaborate with the vendor and internal cross-functional teams to review Quality Agreements
  • Coordinate the PAI readiness of the vendor to maintain inspection readiness
  • Review GMP-related documents as requested and appropriate 
  • Support the development of metric reports for the management of all issues related to the outcome of the audits 
  • Assist in the creation/revision of appropriate SOPs 
  • Other duties as assigned Include high-level responsibilities and day-to-day activities

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 toward 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

  • BA/BS 
  • A minimum of 8 years of experience working in a Biotech or FDA pharmaceutical-regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained 
  • Working knowledge of cGMPs (CFR/ICH) and applicable international regulations/ guidance 
  • Experience reviewing audit reports, quality agreements, and SOPs
  • Prior experience in a commercial product 
  • Previous experience in supporting PAI readiness 
  • Prefer experience in oversight of external vendors 
  • Ability to work in a virtual manufacturing commercial environment 
  • Personal flexibility and a desire to lead, learn, and achieve in a collaborative environment 
  • Ability to travel for both domestic and international business 

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
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$125,000$155,000 USD

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Manager, QA Compliance

Eidos San Francisco, CA/Hybrid Quality Assurance

Apply Now