Manager/Director - QA

COMPANY:

Start-up, preclinical company with several projects focusing on monogenic blood disorders.

Cell and gene-based therapies.

LOCATION:

Greater San Jose, CA area

TITLE:

Manager/Director, QA - full-time, permanent

JOB DESCRIPTION:

Responsible to cover aspects of clinical, nonclinical studies, and manufacturing of therapeutic products.

• Develop and maintain effective in-house quality system
• Manage and oversee GxP training activities across the company
• Conducts GMP, GCP compliance audits of CMO, CRO, clinical vendors, etc.
• Assist clinical trials, manufacturing in defining course of actions related to new processes, deviations, and investigations that may impact drug product quality
• Manage evaluation and approval of Quality System documentation including: deviations, change control reports, specs, test methods, etc.
• Minimal travel at 5-10%

CANDIDATE REQUIREMENTS:

• BA/BS degree and 10 years of experience or advanced degree and 6-7 years of experience in a Biotech or Pharma environment
• Extensive experience in the pharmaceutical industry with Quality Systems and process and/or clinical development background/knowledge
• In-depth knowledge of pharmaceutical cGMP, cGxP
• Experience managing a quality system and its activities

DESIRABLE SKILLSETS:

• Any previous cell or gene therapy experience would be beneficial
• Clinical QA auditing experience

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