Manager, Quality Assurance

Summary

Join Eidos Therapeutics, a BridgeBio Pharma affiliate, as a remote QA Manager focusing on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Manage lot release activities at contract manufacturing organizations (CMOs), acting as a quality liaison. Review manufacturing batch records, certificates of analysis, and issue certificates of compliance. Ensure CMO SOPs and batch records comply with cGMPs. Review deviations, change records, protocols, and CAPAs. This U.S.-based role requires quarterly visits to the San Francisco office. The company offers a competitive salary and benefits package.

Requirements

• Bachelor’s degree with 10+ years of relevant Quality Assurance experience within a pharmaceutical company or contract manufacturing organization
• Prior quality control/analytical chemistry experience
• Working knowledge of ICH, FDA, and Good Documentation Practice principles with a strong understanding of 21CFR210 and 211 and other relevant global regulations
• Ability to engage in cross-functional interactions with internal and external staff
• Excellent verbal and written communications skills, including technical writing, with a strong business customer focus
• Good organizational skills, ability to manage multiple tasks, high throughput, and ability to maintain meticulous attention to detail

Responsibilities

• Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/ protocols, process and method validation protocols, and reports
• Review analytical data and test results to ensure compliance with approved specifications
• Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
• Communicate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
• Represent QA on internal and external project teams, audits, and inspections, and participate in monitoring of CMO performance

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
• 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
• $130,000 — $160,000 USD