Sr. QA Manager (Pharma/Biotech)



  • United States 
  • Last Update: 05.08.2020 at 12:00

Job Type
Full Time
6 Month +
San Diego, CA, US
United States


Sr. QA Manager (Pharma/Biotech)

This Jobot Job is hosted by Emmet Nitto
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Salary $170,000 - $190,000

A Bit About Us

Based in San Diego, CA we are a Biotech Start-Up developing personalized cell therapy, inducing stem cells to treat various neurological conditions. We use personalized regenerative medicine enabling technologies for patient-specific induced pluripotent stem cell-based therapies. We are looking for a Sr. QA Manager (Pharma/Biotech) (Pharma/Biotech) to join our growing team.

Why join us?

  • Competitive Salary!
  • Great Benefits Package!
  • The Opportunity to Join an Amazing Team!

Job Details

  • Minimum of 5 years of progressive Quality department experience in pharmaceutical or biotechnology company
  • Minimum of 4 years of management experience building and overseeing a Quality Department.
  • Experience working with biological products is required
  • Experience with clinical QA responsibilities is a plus; including experience with implementing SOPs to ensure GCP for clinical conduct and oversight
  • Ability to travel up to 10% time based on the requirement to support contracted labs and manufacturers
  • Strong knowledge of FDA and ICH Guidelines including cGMP, GCP and GLP, method qualification and validation requirements, and policies regarding reference standard and specification development
  • Experience with Contract Manufacturing Organizations (CMO) relating to manufacturing and packaging/labeling of clinical trial materials and commercial product
  • Experience managing outsourced QC and characterization testing is required. Experience with the initiation of Quality systems and GMP-compliant QC laboratories is preferred.
  • Strong scientific credentials, and ability to critically assess technical and compliance risks and opportunities, problem solve and communicate complex topics
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel at all levels
  • Effective written and verbal communication skills and computer skills are required
  • Strong problem solving, risk assessment, and impact analysis abilities.
  • Well organized with the ability to multitask in a fast-paced environment.
  • Proficiency with MS Office applications required.
  • Experience with enterprise applications (example MasterControl, Documentum, Trackwise, LIMS, SAP) preferred.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Seniority Level



    • Biotechnology

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