BridgeBio
Sr. Director, Quality Assurance CMC
BridgeBio, San Francisco, California, United States, 94199
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.comWho You Are
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.ResponsibilitiesReview and approve specifications affecting product quality and oversee the development of batch records, validation protocolsOversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of commercial and other late-phase therapeutic areasDisposition of clinical and commercial batchesInteracts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identifiedReview and approve change controls, deviations, investigations, OOX, CAPA, and Product Quality ComplaintsPerforms risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activitiesSupport vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performanceReview clinical and commercial Quality Agreements to meet quality operation and compliance requirementsPrompt communication to management of critical and/or compliance issuesParticipate in Quality Management meetings such as MRB, CCRB, QMR, etc.Review process and method validation protocols and reportsAssist in updating CMC sections of regulatory and quality documentsParticipate in hosting regulatory inspectionsParticipate in the site inspection readiness programSupport internal audit program that is focused on prevention versus correctionParticipate in internal and external project team meetingsSupport QMS in support of late-stage and commercial activitiesParticipates in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to qualityPosition could have a responsibility to manage subordinates in the futureOther duties as assignedNo matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills RequirementsDocumented training and/or certification in relevant quality fields (e.g. ASQ) a plusAt least 15 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; 5 years prior management or leadership role preferredPrevious experience with FDA inspections and interaction with FDAExperience 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 plusDemonstrated track record in effectively managing and implementing GMP-compliant quality systemsExpert knowledge of GMP regulationsExcellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individualsExcellent verbal and written communication skillsAbility to think critically and take a collaborative approach to problem-solvingAbility to work effectively in a regulated and fast-paced environmentDemonstrates a high level of professional integrity and trustworthiness with strong work ethicsPosition requires 10-20% travel. Must have the ability to travel internationallyWhat We OfferPatient 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first. Learn more about how we do this hereA 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 scienceA place where you own the vision - both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timePartnerships with leading institutionsCommitment 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
$230,000-$275,000 USD
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.comWho You Are
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.ResponsibilitiesReview and approve specifications affecting product quality and oversee the development of batch records, validation protocolsOversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of commercial and other late-phase therapeutic areasDisposition of clinical and commercial batchesInteracts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identifiedReview and approve change controls, deviations, investigations, OOX, CAPA, and Product Quality ComplaintsPerforms risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activitiesSupport vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performanceReview clinical and commercial Quality Agreements to meet quality operation and compliance requirementsPrompt communication to management of critical and/or compliance issuesParticipate in Quality Management meetings such as MRB, CCRB, QMR, etc.Review process and method validation protocols and reportsAssist in updating CMC sections of regulatory and quality documentsParticipate in hosting regulatory inspectionsParticipate in the site inspection readiness programSupport internal audit program that is focused on prevention versus correctionParticipate in internal and external project team meetingsSupport QMS in support of late-stage and commercial activitiesParticipates in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to qualityPosition could have a responsibility to manage subordinates in the futureOther duties as assignedNo matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills RequirementsDocumented training and/or certification in relevant quality fields (e.g. ASQ) a plusAt least 15 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; 5 years prior management or leadership role preferredPrevious experience with FDA inspections and interaction with FDAExperience 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 plusDemonstrated track record in effectively managing and implementing GMP-compliant quality systemsExpert knowledge of GMP regulationsExcellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individualsExcellent verbal and written communication skillsAbility to think critically and take a collaborative approach to problem-solvingAbility to work effectively in a regulated and fast-paced environmentDemonstrates a high level of professional integrity and trustworthiness with strong work ethicsPosition requires 10-20% travel. Must have the ability to travel internationallyWhat We OfferPatient 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first. Learn more about how we do this hereA 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 scienceA place where you own the vision - both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timePartnerships with leading institutionsCommitment 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
$230,000-$275,000 USD