Based remotely (with preference for candidates in the Houston, TX, Austin, TX or Boston, MA areas) and reporting to the Executive Vice President & Chief Operating Officer, the Manager, Quality Assurance Operations (QA Manager) will work in conjunction with senior management, quality control, manufacturing, and research to create support Genprex quality. This individual will support the implementation of the QMS system and Quality Manual, while managing the day-to-day quality assurance operations for Genprex.
The QA Manager will be responsible for all drug substance QC testing, quality agreements, investigations, and various other quality systems required to support Genprex. Additionally, the QA Manager is accountable for the assurance of compliance in all activities related to Genprex manufacturing and QC.
- Oversee the implementation and management of the Genprex QMS system and Quality Manual to implement to all appropriate functions within Genprex.
- Write, review, and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.).
- Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met.
- Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories.
- Review and approve validation protocols and reports to ensure compliance.
- Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans.
- Support disposition of finished drug substance, raw materials, and drug products.
- Review stability protocols and reports.
- Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations.
- Conduct internal audits, track progress, and trend results.
- Participate in relevant supplier audits as needed.
- Review relevant sections of regulatory filings.
- Provide guidance on GMP manufacturing from Phase I to Commercial
- Bachelor of Science degree in relevant scientific field.
- At least 5 years’ experience in pharmaceutical development and biotech: in some mixture of roles within Raw Materials, Quality, Manufacturing, Regulatory, and Analytical Development with experience in quality control and/or quality assurance.
- Must possess strong verbal and written communication skills, interpersonal skills, and the ability to develop strong relationships with team members, co-workers, senior leadership, and regulatory agency representatives.
- Must understand cGMP, ICH and USP guidance’s and standards.
- Demonstrated and well-developed organizational and time management skills, as well the ability to effectively articulate, receive, and analyze information as required.
- Must demonstrate strong leadership skills, including team accountability, motivation, coaching and development.
- Strong organizational skills with attention to detail.
- Demonstrated ability to work in a small, hands-on environment.
- Must be highly computer literate with proficiency in Microsoft Office.