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.
VENDOR OVERSIGHT MANAGER/SENIOR MANAGER,
GCP QUALITY ASSURANCE & COMPLIANCE
This is an individual contributor, hands-on position reporting directly to the Associate Director of Good Clinical Practice (GCP) Quality Assurance and Compliance (QA/C). The Vendor Oversight Manager/Senior Manager will be primarily responsible for the overall
oversight of vendors across the Clinical Development areas to ensure compliance with Ionis procedural, contractual, and applicable regulatory requirements along with applying industry best practices. The Vendor Oversight Manager/Senior Manager partners with
various Development Functional Heads or designee(s) who are accountable for the vendors that are contracted to perform clinical, safety, and pre-clinical activities associated with Ionis-sponsored clinical trials.
CORE DUTIES AND RESPONSIBILITIES:
- Oversee and monitor the Clinical Development areas compliance to the vendor oversight related procedures which include qualification, management, escalation, and reporting of quality and compliance related issues. Ensures all applicable deliverables and
documentations are created, retained, and archived per Ionis procedural, contractual, and applicable regulatory requirements
- Understand the business priorities and requirements from various Clinical Development Functional Heads or designee(s) and Clinical Development areas processes and systems as the criteria in developing a risk based and holistic vendor oversight strategy
- In collaboration with the Functional Area Head or designee(s), develop relationships with vendors to enable mutual understanding of expectations, deliverables, and issue resolution
- Perform risk assessment of current and future contracted services as inputs to the vendor oversight strategy
- Implement a risk based vendor oversight strategy for key and preferred vendors including functional service providers
- Develop and manage vendor governance with defined roles and responsibilities, communication pathway, and deliverables
- Lead and facilitate vendor oversight team meetings which include internal and external stakeholders with appropriate representation from various areas as part of the holistic approach
- Work with the Development areas representative to resolve and mitigate vendor performance issues. Perform lesson’s learned as part of the continuous process improvement activities
- Work with internal and external stakeholders to identify key performance indicators (KPIs) in developing Ionis vendor metrics. Ensure periodic evaluation of these metrics to assess trends related to quality and compliance of vendor’s contracted deliverables
and issues. These metrics will be reported and communicated internally
- Develop tools to aid the Clinical Development areas representative in proactively managing their respective contracted vendors
- Create and maintain a vendor database to track which franchise/study and associated services are contracted to key and preferred vendors
- Conduct activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines, as well as all policies and procedures
- Stay current with new or revised regulations, regulatory intelligence, and best practices
- Other activities (e.g., audit, inspection readiness support), special projects, and assignment may be given as required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting will vary depending on
project assignments, current development projects, and the requirements within the organization as a whole
- Minimum Bachelor’s degree in a healthcare or scientific-related discipline
- 5-10 years’ experience and or cumulative experience in the areas of Project Management, Clinical Operations, Procurement, and Quality Assurance in a pharmaceuticals or biotechnology industry
- Good understanding of Development Process
- Effective communication (verbal and written)
- Strong negotiation and interpersonal skills, team player
- Excellent organizational skills with attention to details, advanced computer skills
- Ability to work independently with tight timelines and competing priorities
- Flexible without compromising quality
- Experience writing and reviewing SOPs or tools which support Development activities
- Good understanding of FDA GCP and ICH regulatory requirements, Pharmacovigilance and GLP regulations and implementations
- Good knowledge of Computer System Validation
- Ability to travel up to 30% (domestic and international), sometimes on short notice
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 # 15-0083
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.