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Director of Quality Systems, San Diego

Company Name: Conatus Pharmaceuticals
Location: San Diego
Job Type: Full time, Direct hire
Contact Name: Catherine Donovan
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Commensurate with experience

Job Description

  • Develops and maintains corporate quality policies, procedures and WI.
  • Responsible for implementation of policies & procedures administered directly by Quality Department; document management, personnel training, CAPA system. Provides guidance to other departments developing and implementing policies and procedures governing their activities (GLP/GMP/GCP compliance).
  • Arranges for periodic, independent audits of the quality system to assure compliance and identify areas for potential improvement.
  • Represents the organization to business partners and outside groups, including US and international regulatory agencies. Provide management with process metrics and reports relating to all quality system activities.
  • Assures all employees receive appropriate training.
  • Maintain company (EDMS) and record retention. Update document management system requirements and specifications.
  • Evaluate/qualify material and service suppliers, and arrange for independent audits of such providers. Monitor supplier performance. Execute the release and acceptance of input materials, clinical trial supplies, and approved commercial product.
  • Serves as alternate to VP RA/QA as signatory on Participates in MRB and activities associated with investigation and disposition of material quality issues. Disposition final drug product, Release for human use.
  • Establish annual/long term Quality goals, and lead efforts within Quality to achieve them. Provide input and ideas to improve quality system.
  • Prepare annual operation plan and budget, and ensure the Quality function delivers performance to plan.
  • Perform quality checks of reports, data outputs etc. prior to release or submission to regulatory authorities.

Job Requirements

  • Bachelor’s or Master’s degree in science or business discipline.
  • Minimum 8 years’ experience in quality assurance in medical/pharmaceutical product development industry.
  • Knowledgeable of regulations pertaining to quality system requirements and drug development. Possesses a thorough knowledge of cGLPs/cGMPs/cGCPs/QSRs and other relevant regulations in the US and EU.  Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits.