Associate/Senior Associate, Quality Operations

BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:

Finding the right starting points to target diseases at their source.

Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

Building products with world-class R&D personnel.

We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Who You Are:

The Associate/Senior Associate, Quality Operations is responsible for supporting the Quality and Compliance program's execution at BridgeBio Gene Therapy. This position requires strong communications and organizational skills to maintain compliance with international regulations/guidelines, corporate policies, and standard operating procedures (SOPs). 

Responsibilities:

• Author, review, and route for various controlled document's approval for the Quality organization and other GMP functional areas, including but not limited to SOPs, change controls, material specifications, vendor assessments, qualification protocols, and reports 
• Perform document management activities within the electronic Quality Management System (QMS) 
• Manage the hard copy archiving of Quality System documents  
• Support the Assay Development team in generating quality compliant documentation for analytical method transfers, stability testing activities, and analytical testing SOPs and reports 
• Support the Process Development team in ensuring compliance to Good Regulated Practice (GxP) manufacturing standards and in the generation of quality compliant process development reports and other documents  
• Participate in the oversight of 3rd party manufacturing operations 
• Define, track, and report quality metrics 
• Evaluate Drug Substance and Drug Product test results against approved specifications and reports 
• Provide hands-on Quality support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements 
• Assist in the preparation and performance of audits and inspections, as necessary 
• Participate in risk assessments and cross-functional team discussions in support of deviation investigations and change controls 
• Proactively identify Quality System gaps or enhancements and shepherd to completion, as required 

Education, Experience & Skills Requirements:

• B.S. degree and two years of experience (Associate) or 3-4 years (Senior Associate) in a Q.A. function in a biologics manufacturing facility; Gene therapy experience preferred
• Knowledge of the U.S. and international regulatory standards and guidelines 
• Successful history working in a team environment, meeting deadlines, and prioritizing work over multiple projects 
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others 
• Excellent problem-solving skills and experience with root cause investigations and CAPA determination 
• Strong computer skills, including M.S. Office (Word, Excel) 
• Location in Raleigh, NC, and/or remote 

What We Offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.