BridgeBio Pharma
Sr. Director, Quality Assurance San Francisco, CA/Hybrid
BridgeBio Pharma, San Francisco, California, United States, 94199
About MLBio Solutions & BridgeBio PharmaML Bio Solutions (ML Bio), a BridgeBio company , is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.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.To learn more about our story and company culture, visit us at
ML Bio Solutions
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BridgeBioThe Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at ML Bio Solutions. It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with international regulations/guidelines; corporate policies; and standard operating procedures (SOPs). This individual will be an active participant and key point of contact in the management of regulatory inspections.Responsibilities
Support internal and external GCP audit programDevelopment and management of audit processes/proceduresLead and/or participate in vendor and investigator site auditsReview and/or approval of audit reports and CAPA responsesManage and assist with regulatory inspections and oversee the development and tracking of regulatory commitmentsCommunicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholdersPartner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigationAssist the organization with developing and continuously improving processes and systemsKeep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as neededEducation, Experience & Skills Requirements
Bachelor’s degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical companyCurrent knowledge of global GxP regulationsAbility to engage in cross-functional interactions with internal and external staffExcellent verbal and written communication skills, with a strong customer focusApproximately 15-20% travelWhat 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakA 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 timeCommitment to Diversity, Equity & Inclusion
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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.To learn more about our story and company culture, visit us at
ML Bio Solutions
|
BridgeBioThe Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at ML Bio Solutions. It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with international regulations/guidelines; corporate policies; and standard operating procedures (SOPs). This individual will be an active participant and key point of contact in the management of regulatory inspections.Responsibilities
Support internal and external GCP audit programDevelopment and management of audit processes/proceduresLead and/or participate in vendor and investigator site auditsReview and/or approval of audit reports and CAPA responsesManage and assist with regulatory inspections and oversee the development and tracking of regulatory commitmentsCommunicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholdersPartner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigationAssist the organization with developing and continuously improving processes and systemsKeep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as neededEducation, Experience & Skills Requirements
Bachelor’s degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical companyCurrent knowledge of global GxP regulationsAbility to engage in cross-functional interactions with internal and external staffExcellent verbal and written communication skills, with a strong customer focusApproximately 15-20% travelWhat 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakA 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 timeCommitment to Diversity, Equity & Inclusion
#J-18808-Ljbffr