Senior Manager, Clinical Quality Assurance Job at BridgeBio
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 FIRST
LET SCIENCE SPEAK
EVERY MINUTE COUNTS
THINK INDEPENDENTLY
BE 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 Executive Director, Clinical Quality Assurance, the Senior Manager, Clinical Quality Assurance will assist in the clinical quality oversight and management of GxP activities internally at QED and externally with QED vendors, consultants, and service providers, including, but not limited to, clinical quality systems management, external document review, and approval. The ideal candidate will have experience working in a GCP practice area, preferably in the biotech/pharmaceutical sector.
Responsibilities
- Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
- Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary
- In collaboration with Clinical Operations Project Leads, support project-specific training oversight
- Aid in the authoring and maintenance of QA standard operating procedures (SOPs)
- Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
- Lead small-scale process improvement projects as needed
- Provide clinical quality assurance SME review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, and other clinical trial-related documents
- Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for the adequacy
- Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
- Other duties as assigned or required
- 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
No matter your role at BridgeBio, successful team members are:
Education, Experience & Skills Requirements
- Bachelor's degree in a scientific discipline or equivalent experience
- Minimum of 5 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
- Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
- Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
- Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
- Attention to detail and proper use of tools for information processing and electronic quality management systems
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
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
$155,000 - $170,000 a year
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. The anticipated salary range for candidates for this role who will work in California is
$155,000 to $170,000/year. 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, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
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