Quality Compliance Manager, GXP
- 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 positions us to discover novel pathways and targets in immuno-oncology and will continue to generate important development programs. 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.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity.
The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com
The Quality Compliance Manager, GXP will be a key member of the Quality team reporting directly to the Associate Director, Clinical Quality Assurance. This is an exceptional opportunity to broaden GXP compliance experience in a successful biotech company.
- Serve as a technical subject matter expert (SME) regarding QMS in support of departmental functions.
- Develop, modify, and utilize tools to track and trend areas of deficiency, potential compliance issues, and clinical trial quality.
- Support process improvement initiatives and prepares and analyzes quality metrics of key performance indicators.
- Partner with management and teams to track and report metrics
- Produce reports and status updates for management and leadership
- Work with stakeholders to develop solutions and corrective actions to remediate gaps in identified areas of deficiency such as process improvements or training
- Assist in revising procedural documents to drive and support in-house continuous improvement, including streamlining processes and maintaining GCP compliance
- Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA), product complaints, and monitoring established controls after implementation.
- Participate in and support internal audits and regulatory authority inspections, as required.
- Assist in the planning of compliance assessments including vendor/contractor qualification.
- Participate in strategic, proactive planning of organizational activities, as required, with the goal of providing compliance expertise and to help ensure monitoring is efficient.
- Provide day-to-day support, and problem-solving expertise to applicable business partners to ensure business operations are conducted in full compliance with all relevant policies and procedures.
- Support functional objectives, including risk assessment related initiatives that have a cross-functional or global impact as it relates to a critical compliance issue (s)
- BS/BA degree with 10 years of pharmaceutical industry experience in drug development.
- Minimum 5 years directly related experience supporting drug development in a quality or similar compliance function.
- Knowledge of clinical drug development regulations and ICH GCP.
- Knowledge of QMS and CAPA related tools or systems.
- Clinical Study Management, monitoring or audit experience is an asset
- Experience with health authority inspections and inspection readiness activities preferred.
- Strong personal leadership with demonstrated competency interfacing with senior leaders.
- Working knowledge of US FDA, EU and ICH regulatory requirements and guidelines applicable to clinical research.
- Excellent communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise verbal communication skills).
- Professional and concise written communications–exceptional attention to detail
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
- Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
- Strong project management skills: MS Word, Excel (including Pivot Tables), PowerPoint, Microsoft Project, Visio.
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.