Sr. Director, Quality Assurance CMC San Francisco, CA/Hybrid

3 days ago

Palo Alto CA United States BridgeBio Pharma Full time

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.

BridgeBio Pharma is a virtual pharmaceutical company engaged in the late-stage development of Acoramidis (AG10) for the treatment of Transthyretin Amyloidosis. We seek a Sr. Director, Quality Assurance in CMC team to support the Acoramidis (AG10) program and all BridgeBio Cardiorenal programs. This position reports to the VP of Quality CMC and will work with the CMC team executing late-stage development in support of Phase III clinical trials, launch readiness activities, and commercial quality operations. This position is independently responsible for the operations ensuring compliance with applicable regulatory regulations and other relevant regulations for R&D, commercial production activities, and other late-phase therapeutic areas.

Responsibilities
  • Review and approve specifications affecting product quality and oversee the development of batch records, validation protocols
  • Oversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of commercial and other late-phase therapeutic areas
  • Disposition of clinical and commercial batches
  • Interacts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identified
  • Review and approve change controls, deviations, investigations, OOX, CAPA, and Product Quality Complaints
  • Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities
  • Support vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performance
  • Review clinical and commercial Quality Agreements to meet quality operation and compliance requirements
  • Prompt communication to management of critical and/or compliance issues
  • Participate in Quality Management meetings such as MRB, CCRB, QMR, etc.
  • Review process and method validation protocols and reports
  • Assist in updating CMC sections of regulatory and quality documents
  • Participate in hosting regulatory inspections
  • Participate in the site inspection readiness program
  • Support internal audit program that is focused on prevention versus correction
  • Participate in internal and external project team meetings
  • Support QMS in support of late-stage and commercial activities
  • Participates in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to quality
  • Position could have a responsibility to manage subordinates in the future
  • Other duties as assigned

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
  • Documented training and/or certification in relevant quality fields (e.g. ASQ) a plus
  • At least 15 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; 5 years prior management or leadership role preferred
  • Previous experience with FDA inspections and interaction with FDA
  • Experience in small molecule drug substance and solid oral dose production and development, packaging/labeling/serialization, third-party logistics, and supporting continuous clinical trial medicine supplies. Commercial manufacturing experience is a plus
  • Demonstrated track record in effectively managing and implementing GMP-compliant quality systems
  • Expert knowledge of GMP regulations
  • Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
  • Excellent verbal and written communication skills
  • Ability to think critically and take a collaborative approach to problem-solving
  • Ability to work effectively in a regulated and fast-paced environment
  • Demonstrates a high level of professional integrity and trustworthiness with strong work ethics
  • Position requires 10-20% travel. Must have the ability to travel internationally
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
  • 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
  • Commitment to Diversity, Equity & Inclusion
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