For consideration, please email your resume and cover letter to: hr.rp@revivapharma.com or mail to:

Reviva Pharmaceuticals, Inc.
Human Resources
3900 Freedom Circle, Suite 101
San Jose, CA 95054


Current Open Opportunities

Research & Development

Director/Sr. Director, Quality Assurance (QA)
Revia Pharmaceuticals Inc., a clinical stage San Francisco Bay Area specialty pharmaceutical company, is hiring a Director of QA. The primary responsibility for this position will be establishing and managing the Quality Systems and GxP compliance activities with a focus on continuous improvement.

Essential Duties and Responsibilities include, but are not limited, to the following:

  • Develop, implement, manage, audit and maintain GXP quality systems to support developmental and commercial activities for a pharmaceutical company.
  • Provide leadership to and manage the daily activities of the QA Systems and Compliance.
  • Demonstrate leadership by ensuring the continuous improvement of the Quality Management Systems at CMOs, contract test labs and clinical sites.
  • Ensure management of changes associated with products and processes are carried out appropriately using scientific and risk-based assessments to assess the impact of change.
  • Manage the Internal and External Audit programs to ensure Suppliers are in compliance with applicable regulations. Coordinate and perform all vendor qualification and compliance audits.
  • Coordinate activities and support interactions during regulatory agency inspections and customer audits. Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
  • Develop, manage and maintain a GXP compliant document control system.
  • Ensure key performance indicators measure progress against quality objectives.
  • Monitor, communicate and act on any emerging regulatory and compliance trends.
  • Be a Subject matter Expert for interpreting regulations and applying them to compliance situations as applicable for Phase 1 to 3 drug development programs and or commercial drug manufacturing, testing, packaging and distribution.
  • Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
  • Represent QA at senior management, project, Board, and review meetings.
  • Requirements

  • Minimum BA/BS in life sciences (Biology, Chemistry), Advanced degree preferred.
  • A minimum of ten (10) years of experience in the pharmaceutical or biopharmaceutical industry with increasing levels of responsibility. A minimum of five (5) years relevant experience in a Quality leadership function (QC or QA) is also required.
  • Experience establishing and managing Quality Systems or Supplier Quality is preferred.
  • Hands on experience in writing SOPs.
  • Demonstrated ability in problem solving, strong understanding of cGMP and GxP.
  • Excellent understanding of Quality principles, industry practices, and standards with demonstrated ability to apply these to GMP operations at CMOs and Suppliers.
  • Independent decision making with a high degree of initiative.
  • Extensive knowledge of US Drug Product and API GMP requirements and guidelines.
  • Hands on experience implementing quality systems in a GXP environment, and direct experience with FDA and other health authority inspections.
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
  • Significant hands on experience in a biopharmaceutical company, including clinical and commercial products.
  • Experience in participating in pharmaceutical technology transfer teams.
  • Experience in the qualification of facilities, utilities, equipment and processes.
  • Demonstrated experience and leadership in GxP compliance audits.
  • Excellent verbal and written communication skills, including the ability to lead complex projects. OR Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Ability to critically evaluate and troubleshoot complex problems is essential.
  • 10% to 30% travel required.
  • Motivated self-starter; details and results oriented.
  • Flexible; able to embrace change. Need to be ready to live and embrace the values of the company.
  • For consideration, please email your resume and cover letter to: hr.rp@revivapharma.com or mail your resume to our address.

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