Manager/Sr. Manager, QA
About The Position
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. QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasia, 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 for children living with Achondroplasia and their families. The Manager/Sr. Manager of GMP QA Manufacturing provides on-the-floor quality oversight for GMP manufacturing activities related to API and Finished Drug Product. This role ensures compliance with global regulatory standards (21 CFR Parts 210/211, EU GMP, ICH Q7, ICH Q10) and internal quality systems, while supporting efficient and compliant product release. The Manager/Sr. Manager reviews and approves executed batch records, deviations, investigations, change controls, and associated documentation. They make quality recommendations on the release of API and finished products, ensuring that only compliant materials meeting all specifications are released for use or distribution.
Requirements
- Bachelor's degree in Chemistry, Biology, Pharmacy, Chemical Engineering, or related scientific discipline
- 7+ years of experience in GMP Quality Assurance or Manufacturing within the pharmaceutical or biopharmaceutical industry
- Minimum 3 years in a QA review/release capacity (API and/or finished drug product)
- Strong understanding of cGMP, ICH, and global regulatory requirements
- Experience with contract manufacturing oversight and batch release processes
- Excellent attention to detail and technical writing skills
- Strong communication and decision-making abilities
- Proficiency with eQMS systems (e.g., Veeva, TrackWise, MasterControl)
- Demonstrated ability to interpret complex quality data and make sound, compliant decisions
- 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
Responsibilities
- GMP Oversight and Compliance
- Batch Record Review and Product Release
- Deviation and Investigation Management
- Change Control and Continuous Improvement
- Cross-Functional Collaboration
- Documentation and Training
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
501-1,000 employees
