Senior Manager, Quality Assurance

Summary

Join BridgeBio Gene Therapy, an affiliate of BridgeBio Pharma, as a Senior Manager, Quality Assurance, reporting to the Vice President, Quality. This U.S.-based remote role (with quarterly San Francisco office visits) involves quality oversight and management of internal and external GMP Quality Systems and processes. You will manage quality system processes, author and implement SOPs, develop training, manage batch record review and release, support computer system validation, and assist in inspection readiness. The ideal candidate possesses a Bachelor's degree in a scientific discipline or equivalent experience, at least 7 years of pharmaceutical industry experience in Quality Assurance, and knowledge of GMP regulations.

Requirements

• 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

Responsibilities

• 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

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
• 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
• 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