Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense
drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved
drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets
into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
GCP QUALITY ASSURANCE & COMPLIANCE
This position will be reporting directly to the Head of Good Clinical Practice/Good Laboratory Practice (GCP/GLP) Quality Assurance and Compliance (QA/C). The primary responsibilities will be to ensure quality and compliance of Ionis-sponsored clinical trials
with respect to Ionis’ Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices. The successful candidate will be able to: (1) mentor and manage the activities of internal
& external quality personnel; (2) perform & coordinate internal and external (both domestic and international) GCP related audits & ensure implementation of compliance systems to assure compliance with Ionis Standard Operating Procedures, FDA regulations,
EMA Directives, ICH guidelines, and relevant local/regional regulatory standards; (3) lead/assist in preparation and management of regulatory agency inspections and in enhancing inspection readiness program for Ionis Development; (4) lead/partner with Development
functional area related to quality and compliance initiatives and develop metrics for GCP activities and observations that will form the basis for continuous improvement practices and processes; (5) act as project team compliance member and provide ad hoc
consultation, as needed, to ensure GCP quality and compliance; (6) assist in the review of GCP and systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals; (7) coordinate development, maintenance, and delivery
of GCP training programs; (8) stay current with new or revised regulations.
- Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Clinical Practice (GCP), Pharmacovigilance (PV), Good Laboratory Practice (GLP), and Privacy Requirements
- Ensures the quality & compliance of Ionis’ clinical development & clinical operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
- Prepares and conducts or assists contract auditors for GCP audits per established strategies and plan
- Maintains Audit Files and Tracking Log
- Establishes contract agreements and Statement of Works (SOWs) with the contract auditors according to the internal process with Ionis Legal input
- Conducts risk-based audits of service providers, internal systems and clinical investigators involved with Ionis clinical trial programs
- Assists in the review of clinical trial related SOPs and other controlled / essential documents
- Executes other duties as delegated
- Bachelor and/or Masters in a healthcare and scientific-related discipline is highly desirable
- 10 years of GCP/GLP/PV quality assurance experience in a pharmaceuticals or biotechnology industry
- Good understanding of Clinical Development Process
- Experience writing and reviewing SOPs which support clinical trials
- Good understanding of FDA GCP and ICH regulatory requirements and implementation
- Good knowledge of Computer System Validation in association with GCP/GLP/PV audits
- Effective communication (verbal and written)
- Strong interpersonal skills, team player, and flexible without compromising quality
- Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
- Ability to travel 30% (domestic and international), sometimes on short notice
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website,
www.ionispharma.com. Reference Requisition #17-0058
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.