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.
We currently have an opening for a Director/Executive Director of GCP Quality Assurance and Compliance. This position reports to the Senior Vice President, Legal. The successful candidate will be responsible for managing Quality Assurance and Compliance
activities to ensure compliance with applicable regulatory requirements and best practices for Ionis-sponsored trials and clinical development programs. The individual is responsible for developing the strategy for compliance activities in alignment with
the Company’s goals and objectives by developing and managing a yearly budget, establishing a strategy for quality and compliance activities based on the clinical trial protocols/studies and developmental programs.
Director/Executive Director of Quality Assurance and Compliance– GCP
He/she will participate in the risk evaluation and risk mitigation of Clinical Development programs from protocol development and conduct of clinical trials to finalization of clinical study reports. He/she will act as a subject-matter- expert and advisor
with regards to all applicable domestic (i.e. FDA) and international (including country-specific) regulatory requirements.
The qualified candidate will ensure that all work is performed in adherence to relevant protocols, SOPs, and ICH/GCP regulatory requirements including other country-specific regulatory requirements, when and if applicable. He/she will interact with internal
and external customers, including GLP and PK/Toxicology, as needed. The incumbent will leverage his/her expertise and experience in influencing business partners to progress projects through clinical development phases.
- Devise, manage and improve the company’s GCP/GLP quality strategy and quality management systems
- Interact with clinical development and clinical operations teams to implement strategy and plan /schedule GCP compliance programs
- Manage and mentor direct reports
- Provide strategic, tactical, and operational leadership in planning and executing established QA activities
- Coordinate, prioritize, and delegate audits to either internal staff or experienced and qualified contract auditors
- Review and approve audit reports and CAPA/responses received from auditees
- Coordinate and/or participate with a GLP representative for pre-assessments or audits of bioanalytical labs supporting analysis of clinical trial samples
- Communicate audit findings clearly with internal/external customers and auditees Provide guidance, solutions, and advice on complex problems or issues related to quality and compliance
- Review and approve internal SOPs (new or revised)
- Regularly attend Clinical Trials Team meetings
- B.S. Degree in a life sciences discipline required; advanced degree in a scientific discipline preferred; Medical Technology Degree or hands- on experience in a research laboratory is a plus
- Minimum 15 years of pharmaceutical or biotechnology industry experience with at least 10 -12 years’ direct experience in GCP Quality Assurance and Compliance
- Maintain a broad knowledge of drug-development regulatory requirements and proficiency in ICH guidelines and FDA/international regulations relating to clinical development
- Strong leadership skills, including effective facilitation and communication abilities
- Strong judgement and decision-making skills with the ability to understand how decisions fit into corporate strategies
- Experience with clinical trial logistics, including auditing clinical trials and assessing capabilities of potential clinical and non-clinical development programs from a quality and compliance perspective
- Demonstrated ability to manage, train and develop direct reports
- Drive implementation of company initiatives in terms of quality assurance and compliance with emerging domestic and international guidelines and regulations
- Possess the ability to manage multiple projects simultaneously at a high level of productivity with aggressive timelines
- Proficient computer skills i.e. Microsoft office, databases, electronic documentation system are required
- Strong project management skills desired
- Familiarity with computer validation and part 11 compliance is desired.
- Knowledge of non-clinical development process is preferred
Excellent salary and benefits package offered.
For more information on Ionis and to apply for this position, please visit our website,www.Ionispharm.com. Reference Requisition # 17-0058
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.