Ionis Pharmaceuticals, Inc. · 2 weeks ago
Assistant Director, GxP Quality Systems (QA Vendor Management)
California, United States
Full-time
Hybrid
Director/Executive
$110K/yr - $154K/yr
8+ years expIonis Pharmaceuticals, Inc. is headquartered in Carlsbad, California, and is a pioneer in RNA-targeted medicines. They are seeking an experienced Assistant Director to lead Quality Systems and Vendor Management, focusing on compliance, audits, and vendor oversight to ensure quality and regulatory adherence.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead and execute Internal Audit Program in accordance with established procedures and through application of risk management to always ensure site compliance and inspection readiness
Independently lead and execute GMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices
Lead and manage Quality Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with GMP vendors
Manage Vendor Change Notifications collaborating with customers / stakeholder regarding impact and quality assessments and ensuring adherence to vendor change timelines and internal / regulatory requirements, as applicable
Lead investigations and/or analyze and trend Vendor Quality Events (i.e., Deviations including CAPA management and effectiveness checks, as required)
Adhere to standard process lead times and ensures alignment with key performance indicators and relevant measures / metrics
Possess strong intra- / inter-company communication skills, ability to think critically and influence others, problem solve, and have solid technical writing skills
Demonstrate ability to work independently, be organized, multi-task and adjust priorities in a dynamic, fast paced work environment
Collaborate with others while leading projects that drive continuous quality improvements, implement best practices and /or enhance compliance to domestic and international regulatory requirements
Qualification
Required
B.S. in Chemistry, Chemical Engineering, or a relevant Life Science degree; advanced degree preferred
Requires a minimum of 8 years in the Life Sciences or Pharmaceutical industry with relevant Quality Assurance experience and 5+ years of GMP Vendor Management experience; or an advanced degree with lesser experience or alternate equivalent work experience
Expert knowledge of domestic and international GMP regulations
Experience in leading projects, problem solving, process improvement with strong negotiation skills
Possess strong intra- / inter-company communication skills, ability to think critically and influence others, problem solve, and have solid technical writing skills
Demonstrate ability to work independently, be organized, multi-task and adjust priorities in a dynamic, fast paced work environment
Committed to delivering high quality results, overcoming challenges, focusing on what matters to achieve corporate, department and personal goals and objectives
Continuously looking for opportunities to learn, build skills and share learnings both internally and externally
Travel up to 20% may be required
Preferred
Advanced degree preferred
Experience and understanding of product formulation and filling, and assembly of drug delivery devices (i.e., combination products), is preferred
Experience and understanding of Antisense Oligonucleotide manufacturing processes is desired
Benefits
Ionis offers an excellent benefits package!
Company
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.
501-1000 employees
H1B Sponsorship
Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45B2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M
Leadership Team
Brett P. Monia
Chief Executive Officer
Eric Bastings
Senior Vice President, Development Strategy
Recent News
2026-01-08
Company data provided by crunchbase