SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Quality Manager/Assistant Director, GLP/GCP Quality Assurance & Compliance

Company: Ionis Pharmaceuticals, Inc.
Location: Carlsbad
Posted on: November 22, 2020

Job Description:

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 conducting GLP/GCP internal and external audits to ensure quality and compliance of non-clinical study and 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. In addition, support the implementation of the Vendor and Risk Management Programs in the Development space. RESPONSIBILITIES: Lead/support investigator site, vendor, and internal process audits per Ionis procedures and applicable regulatory requirements. Support the implementation of the Vendor Oversight Program for Development non-clinical and clinical programs/studies with the focus on quality and compliance perspectives. Work closely with the Vendor Oversight Program Lead (VOPL) to define and execute appropriate oversight for key and non-key vendors per internal procedures and ICH E6/other regulatory requirements. Monitor/adjust the oversight activities throughout the lifecycle of the contracted services. Support/facilitate the Governance Meeting for assigned vendor(s) which include collaborating with the VOPL, Functional Areas, and key vendor---s representative in developing the agenda, taking meeting minutes/actions, and managing the actions to completion. Act as the point of contact for Ionis and work with the key vendor---s representative in the overall management of the assigned Governance. Escalate issues to the VOPL and communicate relevant information and updates to all applicable internal and external stakeholders in a timely manner. Support the management of vendor risk assessment on a yearly basis or as needed to identify which vendors will be audited and included in the annual audit plan. Partner with the Functional Areas and QA/C personnel to ensure relevant/key vendors are identified and assessed as part of QA/C---s risk-based audit strategy. Support the QA/C Audit Program by ensuring vendor related information are provided to the audit team during audit preparation, review audit deliverables as applicable, and attend pre-audit /post audit debrief. Support with the Development Functional Areas related to vendor oversight initiatives including creating/updating the vendor related procedures and associated tools. Train Development personnel and QA/C colleagues on vendor related procedures, tools, systems, and governance process. Support the implementation of a risk management program for the Development Functional Area per ICH E6. Assist in preparation and/or management of regulatory agency inspections and in enhancing inspection readiness program for Ionis Development. Assist in the review and/or approval of GLP/GCP and systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals. Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Pharmacovigilance (GVP), and Privacy Requirements Executes other duties as delegated EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS Education: Bachelor---s Degree and/or equivalent combination of education and experience 5-10 years of GLP/GCP/GVP quality assurance experience in a pharmaceutical or biotechnology industry; Project Management experience and skills a plus Good understanding of preclinical, clinical development, and drug safety Experience writing SOPs which support GLP/GCP/GVP activities Experience in auditing and implementing FDA CFR and EU ICH regulatory requirements and other global ICH harmonization regulations Good knowledge of Computer System Validation related to predicate rules 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 up to 20-40% (domestic and international), sometimes on short notice Competencies regarding regulatory requirements in clinical and/or pre-clinical trials Ability to work efficiently and independently Excellent oral and written skills Ability to communicate efficiently across departments and levels

Keywords: Ionis Pharmaceuticals, Inc., San Diego , Quality Manager/Assistant Director, GLP/GCP Quality Assurance & Compliance, Executive , Carlsbad, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Associate Director, Accounting and Taxation
Description: 106871 ASSOCIATE DIRECTOR, ACCOUNTING AND TAXATION br br Filing Deadline: Fri 12/4/2020 br br The effects of the COVID-19 pandemic have impacted UC San Diego Campus hiring. UCSD Campus will continue (more...)
Company: University of California - San Diego
Location: San Diego
Posted on: 11/28/2020

#106842 Project Manager - Clinical Trials Project Mgmt
Description: 106842 PROJECT MANAGER - CLINICAL TRIALS PROJECT MGMT br br Filing Deadline: Mon 12/7/2020 br br This position is a contract position with the possibility of extension/career conversion. br (more...)
Company: University of California - San Diego Medical Cente
Location: San Diego
Posted on: 11/28/2020

Manager, Drug Safety and Pharmacovigilance Operations
Description: Who We Are:At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate (more...)
Company: Neurocrine Biosciences
Location: San Diego
Posted on: 11/28/2020


Assistant Store Manager
Description: JOB SUMMARY br The Spectrum Assistant Store Manager is responsible for assisting the Store Manager in building a highly successful sales, retention and customer care culture inside their store. Actively (more...)
Company: SPECTRUM
Location: Long Beach
Posted on: 11/28/2020

Assistant Store Manager
Description: JOB SUMMARY br The Spectrum Assistant Store Manager is responsible for assisting the Store Manager in building a highly successful sales, retention and customer care culture inside their store. Actively (more...)
Company: SPECTRUM
Location: San Diego
Posted on: 11/28/2020

Operations Manager
Description: DesciptionNow is the time to join Pacific Dental Services Supported Office. You will have opportunities to learn new skills from our team of experienced professionals. If you're ready to take your career (more...)
Company: Pacific Dental Services Supported Offices
Location: San Diego
Posted on: 11/28/2020

Senior Cloud Operations Manager, AWS
Description: Job Description Senior Cloud Operations Manager, AWS Location: San Diego, CA Job
Company: Teradata
Location: San Diego
Posted on: 11/28/2020

Senior Director, Developmental Services
Description: JOB SUMMARY: br br The Senior Director, Developmental Services has the overall responsibility for the management, coordination, planning, evaluation of the diverse functions and activities of Developmental (more...)
Company: Rady Children's Hospital
Location: San Diego
Posted on: 11/28/2020

Sales Manager
Description: Sales Manager br br br San Diego, California 92123 br br br Who you are br br 2 years of sales management and 5 years of sales experience preferred but not required. br The ability to (more...)
Company: Xerox
Location: San Diego
Posted on: 11/28/2020

IT Service Desk Manager in San Diego
Description: Our client is an established healthcare organization seeking an experienced IT Service Desk Manager for its IT department. This organization was founded with a mission to serve those who need help the (more...)
Company: Mission Recruiting
Location: San Diego
Posted on: 11/28/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds