Employer: FUJIFILM Diosynth Biotechnologies Texas, LLC
Implement and maintain quality systems supporting the start-up of a GMP compliant manufacturing and drug product facility. Responsible for the readiness of the required quality systems to support GMP manufacturing upon completion of the start-up activities.
Implement site specific Quality Risk Management principles and risk-based processes, aligning with the company's global approach, which are designed to ensure product quality and patient safety while maintaining business continuity and meeting regulatory expectations. Evaluate and recommend Quality Assurance personnel.
Provide development plans and leadership for Quality Assurance personnel.
Partner with Manufacturing, Facilities, Engineering and Validation groups to implement global and site specific quality and risk management principles to ensure patient safety and product quality. Collaborate with site leadership to develop and maintain a risk-based strategic Quality and Compliance plan for the three Texas facilities - Early Phase, Late Phase, and Monoclonal Production facilities, that will meet US and EU requirements for cGMP manufacturing of drug substances and sterile drug products. Identify, schedule by priority, and implement quality systems in alignment with FDB policies and procedures.
Provide regular updates and reports to Quality management. Support due diligence audits. Support client person-in-plant representatives.
Review and approve technical documents, including Process Specifications, Standard Operating Procedures, User Requirement Specifications, Master Batch Production, Records Commissioning, qualification and validation protocols and Reports. Work with Quality management to implement and grow phase-appropriate quality systems. Collaborate with Manufacturing, Facilities, Engineering, and Validation on key facility, utility and equipment decisions and their qualification.
Collaborate with the Microbiology group and subject matter experts to design, implement and maintain a contamination control strategy to prevent cross-contamination of manufactured products. Support internal quality audits of Facilities and Validation. Act as QA liaison to internal departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
Lead deviation investigations and CAPAs related to the facility, utilities, and state of control of the Saturn facility. Assist with the execution and harmonization of the Quality Management System across the FDBT site. Reqts: Bachelor's degree or equivalent in Microbiology, Chemistry, Biology, Life Sciences, Biotechnology, or a related field, and 6 years of experience in the position offered or related, including 6 years of experience with Overseeing quality assurance in a regulated pharmaceutical, biotechnology, or supporting Contract Development and Manufacturing Organization (CDMO) environment; U.S. and European cGMP regulations for the production of drug, biologics or vaccine products; Hosting or supporting regulatory agency site inspections; Managing client interactions and fulfilling obligation relating to Quality aspects of contract manufacturing in relation to the Quality Agreement; and including 3 years of experience with:
Designing and bringing online new biotechnology manufacturing facilities; Facility engineering and commissioning, biotechnology manufacturing, utility commissioning, regulatory approval process and requirements. E-mail resume to FUJIFILM Diosynth Biotechnologies Texas, LLC at firstname.lastname@example.org and reference position title in subject line.