Job description
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you’re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask “why not?” and help reengineer the future of biopharma.
Affiliate Overview
BridgeBio Gene Therapy, an affiliate within of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous rare genetic diseases by finding the right starting points to target diseases at their source and by building products with a world-class R&D personnel team. 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.
What You’ll Do
Reporting to the Vice President, Quality, the Senior Manager, Quality Assurance will assist in the quality oversight and management of internal and external GMP Quality Systems and processes including, but not limited to:Vendor Management, Metric reporting, Deviation and CAPA management, and change control including experience in QA review and release of clinical and/or commercial batches. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.
Responsibilities
Responsibilities specific to BBGT:
- Management and maintenance of quality system processes such as Document Control, Change Control, Deviations, CAPA, and Effectiveness Checks
- Author, revise and implement QA GMP standard operating procedures (SOPs)
- Develop and deliver training on GMP SOPs and systems
- Timely management of batch record review and release to ensure continuous supply for clinical trials and marketed products
- Assists in the management, maintenance, and evaluation of BBGT’s Quality Management Systems processes for optimization and continuous improvement
- Support computer system validation, including the development and execution of system validation plans and performance qualification testing
- Ability to effectively multi-task to meet deadlines and commitments
- Assist in inspection readiness activities for GMP activities at BBGT
- Other duties as assigned or required
Where You’ll Work
This is a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office.
Who You Are
- Bachelor’s degree in a scientific discipline or equivalent experience
- Minimum of 7 years pharmaceutical industry experience in Quality Assurance or other relevant roles
- Knowledge of applicable GMP regulations (e.g., CFRs, EuraLex and ICH)
- Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
- A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
- 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 systems
- Other skills and abilities as required
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing:
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
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—$180,000 USD
