Senior Manager/Associate Director QA Compliance

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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 San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

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

Location

San Francisco, CA

Who You Are

The Sr. Manager/Associate Director of QA Compliance provides audit and compliance oversight at Eidos Therapeutics and contract manufacturing, testing, research, and/or laboratory organizations. This position reports to the Sr. Director QA. 

Responsibilities

  • Provide audit and compliance oversight of the contract manufacturing, testing, research, and/or laboratory organizations including, but not limited to: audits, manage quality agreements, product complaints
  • Participate in the vendor qualification; review, evaluation, and approval of contract manufacturing, testing, research, and/or laboratory facilities
  • Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
  • Coordinate and manage PAI readiness of the vendor to maintain inspection readiness.
  • Promote/advance quality awareness; coordinate and provide training
  • Review and approve GMP related documents as requested and appropriate
  • Participate on project teams and sub-teams as needed and assigned
  • Develop metric reports for management of all issues related to the outcome of the audits
  • Assist in the creation/revision of appropriate SOPs
  • Ensure documents and records are kept in compliance with regulations and SOPs

Education, Experience & Skills Requirements

  • BA/BS
  • A minimum of 10 years of experience working in a Biotech or Pharmaceutical FDA 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 with implementing and maintaining pharmaceutical quality systems
  • Experience writing and presenting clearly on quality topics such as audit reports, quality agreements
  • Prior experience in a commercial product
  • Prior 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 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
careers

Senior Manager/Associate Director QA Compliance

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