Senior Delivery Manager responsible for the effective delivery of digital products at CCS. Leading multidisciplinary teams and ensuring alignment with government service standards through agile methodologies.
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
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