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Reviva Pharmaceuticals, Inc.
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
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.
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: email@example.com or mail your resume to our address.