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Sr. Director, Quality Assurance CMC San Francisco, CA/Hybrid - Palo Alto, United States - BridgeBio
Description
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.
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 todiscover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseasesand 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.
ResponsibilitiesReview 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 plusDemonstrated 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
An unyielding commitment to always putting patients first. Learn more about how we do this here
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
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.#J-18808-Ljbffr
