Manager, GMP Quality Systems & Compliance
- 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.
The primary responsibility for this position will be refining and managing electronic Quality Management System and GXP compliance activities with a focus on continual improvement. This is a key quality management role reporting to the Senior Director of Quality Assurance.
- Partner with IT Compliance to provide quality risk assessment of computerized systems and implement computerized systems for GxP purposes
- Provide quality evaluation of change controls affecting validated computerized systems for GxP purposes
- Review and approve user requirements, functional specifications, IQ/OQ/PQ protocols and reports for validation of computerized systems for GxP purposes
- Manage and be the technical subject matter expert (SME) for the electronic quality management system
- Manage paper-based systems for reporting of deviations, CAPAs, and product complaints
- Partner with IT Compliance to implement electronic management systems for reporting of deviations, CAPAs, and product complaints, including refinement of existing and/or creation of new pertinent SOPs and/or work instructions
- Conduct internal audits (with guidance from the Lead Auditor as applicable) of internal processes and procedures to ensure GxP compliance
- Conduct external audits of GxP contract service providers as commensurate with prior auditing experience
- Assist in the planning of compliance assessments including qualification of GxP contract service providers
- Develop, modify, and utilize tools to track and trend areas of deficiency and potential compliance issues; monitor, communicate, and act on any emerging trends
- Generate quality metrics for quality systems to ensure key performance indicators measure progress against quality objectives
- Coordinate and manage compliance related activities in preparation for regulatory agency inspection and support interactions during regulatory agency inspections and customer audits
- Manage follow-up within the 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
- Provide back-up support to Quality Operations as needed
- Be flexible and prepared to perform other related tasks as assigned
- Other duties as assigned
- BS/BA degree with 10 years of pharmaceutical industry experience in drug development
- Minimum 5-7 years directly related experience supporting drug development in a quality or similar compliance function
- In-depth knowledge of GMP and ICH requirements and guidelines for manufacture of biologics and 21 CFR Part 11 regulations and GAMP requirements for computerized systems
- Working knowledge of US FDA, EU and ICH regulatory requirements and guidelines applicable to clinical research
- Experience with implementation and management of electronic quality management systems
- Ability to effectively interacts with internal peers and site management to lead continuous improvement
- Experience with internal/external audits, health authority inspections and inspection readiness activities
- Excellent communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise verbal communication skills)
- 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 fast-paced environment and the 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
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.