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Manager, R&D and Clinical QA

  • Location
  • Job type Permanent
  • Reference BBBH115504

COMPANY:

Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)

LOCATION:

Greater San Francisco area

TITLE:

Manager, R&D & Clinical Quality Assurance

TYPE:
Full-time, direct hire

RELOCATION ASSISTANCE:

Yes

ROLE RESPONSIBILITIES:

This individual will be responsible for providing quality oversight for the R&D and clinical programs related to the company's genome editing and AAV gene therapy.

CANDIDATE REQUIREMENTS:

  • Minimum of a Bachelor's degree in life science or equivalent .
  • Demonstrated in-depth experience of establishing, refining and operating R&D and Clinical Quality Assurance related systems in the Biotechnology industry.
  • 5+ experience in a combination of R&D Quality Assurance and Clinical Operations roles.
  • 8+ years' experience working in a regulated industry.
  • In depth knowledge of FDA, ISO, EMA, GMP, GCP and ICH quality systems and regulatory requirements for clinical programs including cell-based, gene-based and rAAV-based therapies.
  • In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA and WHO regulations a plus.

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.