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
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