SRI's Biosciences Division develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the breadth - and depth - to deliver the latest in biomedical research through technology development. Our researchers have a rich legacy of collaboration with government agencies and industry partners that improve health outcomes and well-being around the world. SRI Biosciences projects range from high-impact, early-stage research to drug co-development with pharmaceutical and biotech companies. Regulated work conducted by SRI staff includes safety testing, clinical manufacturing and Phase I-IV clinical trials. SRI, working with its partners and collaborators, has advanced over 225 drugs into clinical trials, and at least 25 have achieved market approval.
The Quality Assurance Unit (QAU) Manager leads the SRI Biosciences Division’s Quality efforts. Primary responsibility is to provide quality assessment to Good Laboratory Practice (GLP) / current Good manufacturing Practice (cGMP) / Quality System Regulation (QSR) programs. This is accomplished through proactive inspections and retrospective data / report audits to ensure that all work is conducted in accordance with FDA regulations, international regulations, protocols, Standard Operating Procedures (SOPs), and corporate policies.
Ensures that personnel, methods, corporate policies and standard operating procedures comply with: FDA requirements for Good Laboratory Practices (GLP) for conducting scientific research, current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), Good Clinical Practices (GCP), and 21 CFR Part 11. Performs internal GLP, cGMP, QSR, GCP and Part 11 audits as well as external audits of laboratory facilities, protocols and reports. Provides quality guidance to project teams.
Serves as advisor and spokesperson to management and represents Quality Assurance function on major matters pertaining to its policies, plans, and objectives. Often performs in a Quality leadership role. Applies wide-ranging experience with quality concepts and SRI objectives to resolve complex issues in creative and effective ways. Manages cross-functional teams focusing on internal or external client projects. Contributes to development of new concepts, techniques, and standards.
Participates with other senior managers to establish strategic plans and objectives. Is involved in issues requiring analysis of situations or data and in-depth evaluation of variable factors. Makes final decisions on administrative or operational matters. Works on complex issues for which analysis of situations or data requires an in-depth knowledge of SRI. Networks with key contacts outside own area of expertise.
This job will be based in Menlo Park, CA. It is a flexibly hybrid role where time can be spent working from home, but there will also be requirements to come into our facility in Menlo Park for specific times.
Required:
Preferred:
The salary range is: $109,000-$135,000/hr. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program.
SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.
Software Powered by iCIMS
www.icims.com