Sr. Manager/Associate Director, Quality Assurance

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

Our Business Is Inspired By Our Values

PUT PATIENTS FIRSTLET SCIENCE SPEAKEVERY MINUTE COUNTSTHINK INDEPENDENTLYBE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com

Who You Are

Reporting to the Director, Quality Assurance, the Senior Manager/Associate Director, Quality Assurance will assist in the quality oversight and management of internal and external GXP Quality Systems including, but not limited to: Batch Record Review and Release, Investigations, CAPA, Product Quality Complaints, and external document review and approval. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.

Responsibilities

Timely management of batch record review and release to ensure continuous supply for clinical trialsManagement and maintenance of quality systems such as Training, Change Control, Deviations, CAPA, Effectiveness Checks, and Product Quality ComplaintsExperience with analytical instrumentation, methods, validation, and investigations including stability program managementAbility to effectively multi-task to meet deadlines and commitmentsAssist in inspection readiness activities for GXP activities at QEDAuthor and implement QA GXP standard operating procedures (SOPs)Develop and deliver training on GXP SOPs and systemsAssist in the preparation of GXP metric reports for annual review with the Senior Management teamOther duties as assigned or required including BridgeBio affiliate support

No 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 speed

Education, Experience & Skills Requirements

Bachelor's degree in a scientific discipline or equivalent experienceMinimum of 7 years of pharmaceutical industry experience in Quality Assurance, as well as experience in small and large molecules in both clinical development and commercial manufacturingThorough knowledge of applicable regulations such as 21CFR Part 11, 210, 211, 312 and 314; ICH Q1–Q10 and E6Attention to detail and proper use of tools for information processing and electronic quality management systemsAbility to effectively multi-task to meet deadlines and commitments

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 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 time Partnerships 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

$150,000—$190,000 USD