Hybrid Quality Control Manager

at BridgeBio

• Job title: Quality Control Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $120,000 - $150,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Manager of Quality Control ensuring compliance with cGMP in pharmaceutical settings. Overseeing analytical data and collaborating with contract labs at BridgeBio Pharma.

Responsibilities

• Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results
• Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages
• Submitting test packages to QA for their review and loading all data into the electronic storage program
• Review of analytical data related to reference standard qualification, method validation and method transfer activities
• Travel, when necessary, to analytical testing sites or other sites
• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
• Create or review BBio Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories

Requirements

• M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP)
• 2+ years management experience
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Proven abilities in leadership and personnel management
• Strong oral and written communication skills
• Excellent organizational and planning skills and high attention to detail
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines
• Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities

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