Director of Quality Assurance ( QA / QC)
Sterling Life Sciences - San Francisco, CA

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1) Oversee CMOs and liaise with the company's Chemistry, Manufacturing and Control (CMC) team and functional management with regards to quality related issues
2) Interact with QA management at both the CMOs and company on matters concerning the product quality and CMO GMP compliance
3) Oversee quality assurance of overseas CMOs and suppliers
4) Interact with overseas CMO senior leaders to ensure that company QA / GMP interests are met and that relationships are properly maintained
5) Establish quality agreements with CMO's
6) Review Master Batch Record (MBR) and approve for compliance with good manufacturing practice regulations, regulatory filings and quality agreements
7) Review executed batch records, certificates of analysis and other documents to enable drug substance and final drug product release certifying batches as GMP compliant
8) Review and communicate deviations at CMOs to company CMC teams and functional management
9) Obtain and communicate company's deviation investigation requirements to CMOs and work with CMOs to investigate deviations until resolved
10) Review equipment qualification protocols and reports
11) Communicate changes between company and CMOs
12) Monitor documentation and implement changes until completed successfully
13) Perform contractor quality system review and gap analysis as part of CMO selection and maintenance
14) Work with new CMOs to certify them as ready to begin manufacture of company's products intended for administration to humans
15) Review and approve contractor documentation required for the manufacture and testing, as well as approve technology transfer protocols, discrepancies, deviations and reports
16) Conduct GMP compliance audits of contractors and suppliers
17) Review CMC sections of regulatory filings
18) Provide support before and during governmental regulatory agency inspections of company and company's contractors
19) Develop, refine and manage internal company quality systems

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in quality assurance management

About this company
The Life Sciences practice of Sterling-Hoffman was formed with a simple purpose: help biotechnology, pharmaceutical & medical device...