Senior Manager, Clinical Quality Assurance
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.
We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
Reporting to Senior Director of Quality, we are seeking a highly motivated and ambitious individual to join the Quality team as Senior Manager, Clinical Quality Assurance. This individual will provide QA support to ensure compliance with Good Clinical Practice (GCP). Areas of responsibility include:
- Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Partner with the Clinical department to ensure all clinical trials are assessed for compliance with Five Prime SOPs, FDA and ICH/GCP guidelines and other applicable regulations.
- Plan and conduct internal audits. Partner with internal Clinical stakeholders to manage identification of the root cause in pertinent clinical quality management processes and to develop remediation plans and resolve the audit findings and/or significant protocol deviations.
- Plan and conduct external audits, including clinical contract service providers (CROs, contract clinical laboratories, specialty laboratories, etc.) trial master file, clinical investigator sites, clinical documents, and other internal procedures and systems.
- Generate audit reports and communicate effectively across departments on compliance issues and/or risks as applicable. Resolves compliance issues and assess the impact of any deficits.
- Maintain and track response to audit findings and other clinical CAPAs. Follow-up with stakeholders for CAPA remediation activities to ensure actions are assigned and completed.
- Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables, and listings, informed consents, investigator brochures, and Clinical Study Reports).
- Represent Clinical Quality Assurance at meetings, communicating compliance perspectives and risks.
- Participate in the evaluation, qualification, and selection of CROs and other clinical and nonclinical service providers and support due diligence activities as needed.
- Participate in corporate audits and regulatory authority inspections, project team meetings, and GCP training activities, as required.
- Assist the quality team with all other clinical quality assurance activities.
- Other duties as assigned.
- BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree is desirable
- 10 years of relevant pharmaceutical industry experience with a minimum of 4 years of GCP compliance experience
- In-depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines
- Experience in planning and conducting GCP and GLP audits
- Experience with regulatory inspections and inspection readiness (EU experience and experience with pharmacovigilance QA is a plus)
- Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA programs)
- Experience reviewing and auditing study-related documentation (e.g. clinical trial protocols, informed consent forms, clinical study reports, Investigator Brochures, etc.)
- Experience in the use of relevant computer systems used in clinical and non-clinical research including safety databases
- Familiarity with signal detection systems is a plus
- Excellent interpersonal and written communication skills
- Ability to influence and negotiate effective solutions
- Strong critical thinking and decision-making skills
- Must be able to travel up to 20%
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.