Remote Quality Control Manager - Biopharma

BridgeBio; United States; Remote; USD 144,000 - 160,000; Full time

Benefits offered by this job

401k match

ESPP

Hybrid/Remote flexibility

Health benefits

Parental leave

Job summary

BridgeBio seeks a Quality Control Manager to ensure analytical testing at CMOs complies with cGMP. You’ll review test packages for release, stability, and in-process testing, and oversee deviations and investigations.

The role is remote within the U.S. with periodic visits to the San Francisco office. Requires MS/BS in life sciences and 5+ years in pharmaceutical QC, plus 2+ years of people-management experience.

Qualifications

• 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.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.

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

Skills

Quality Control

cGMP knowledge

Analytical chemistry

Vendor communication

Project management

Education

M.S./B.S. in life sciences

Chemistry/Analytical Chemistry preferred

Job description

BridgeBio seeks a Quality Control Manager to ensure analytical testing at CMOs complies with cGMP. You’ll review test packages for release, stability, and in-process testing, and oversee deviations and investigations.

The role is remote within the U.S. with periodic visits to the San Francisco office. Requires MS/BS in life sciences and 5+ years in pharmaceutical QC, plus 2+ years of people-management experience.