Assistant Directory, Quality Assurance
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.
ASSISTANT DIRECTOR, QUALITY ASSURANCE
This individual’s primary responsibility will be to assist the Executive Director with the oversight of Drug Substance (DS) and Drug Product (DP) and Finished Goods (FG) manufacturing and testing activities performed by contract manufacturer and contract test labs. The successful candidate will be able to: (1) ensure progress and completion of responsibilities in accordance with established departmental goals and objectives or project plans and milestones; (2) fulfill the requirements of Ionis’ Quality System procedures including but not limited to change control, corrective and preventive actions, deviations and investigations, external audits, risk management, quality agreement and CMO oversight, product complaints, etc.; (3) use judgment [with consideration to risks and mitigation strategies] to develop solutions to a variety of complex problems and issues; and (4) perform / manage data integrity activities [including oversight of data at CMOs and CTLs] in support of regulatory applications and filings.
MAJOR AREAS OF RESPONSIBILITIES:
• Ensure the compliance of Ionis’ contracted manufacturing and testing activities to internal quality system elements, as well as to FDA, EMA, Health Canada, MHLW, ICH, and other jurisdiction’s regulatory expectations and guidelines related to current Good Manufacturing Practices (cGMP), as applicable
• Prepare / review / approve technical reports related to quality operations related to the manufacture or testing of intermediates, DS and DP
• Coordinate review and approval of change control records for commercial drug substance and drug products manufactured at CMOs
• Provide quality input and decisions in cross functional meetings with Ionis’ business partners and CMOs
• Review and provide input [e.g. troubleshooting, failure analysis, problem solving, and risk management (assessment and mitigation)] for quality activities and events contracted to the manufacture or testing of intermediates, DS and DP
• Perform external audits of Ionis’ suppliers, CMOs, as directed
• Support the conduct of domestic and international regulatory authority audits or inspections
• Perform / manage data integrity activities in support of regulatory applications and filings
• Provide quality oversight for design control reviews in compliance with combination drug product regulations.
• Implement / manage selected quality programs and systems (e.g., quality agreements, etc.)
• Coordinate specification committee and Material Review Board meetings. Facilitate internal review of specification review and approval processes
• Develop, implement and deploy enhancements to quality system policies and procedures
• Other duties, as assigned
This position requires a Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, engineering, etc.) with at least 10 years of experience in the pharmaceutical industry and at least 6 years of Quality Assurance experience in a cGMP environment.
This individual will have and maintain proficiency in FDA, EMA, Health Canada, MHLW, ICH, and other jurisdiction’s regulatory expectations and guidelines related to cGMP activities. This person must have comprehensive knowledge and experience in making risk-based decision in compliance with ICH Q7, 21 CFR 820, 21 CFR Part 11 and Annex 1 guidelines. Prior experience with combination drug product design control reviews is required. Expertise in quality review of software validation is desired. In addition, this person must possess effective communication (verbal and written), interpersonal, and teamwork skills. This individual must also be able to manage multiple priorities with aggressive timelines at a high level of productivity.
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.