Summary
Overview
Work History
Education
Skills
Certification
Clinical Summary
Affiliations
Accomplishments
Timeline
Generic

Shanita Jones

San Diego,CA

Summary

I am a highly motivated leader with a successful distinguished career in Supplier/Vendor Quality, Quality Systems, and Risk Management in the Pharmaceutical industry. I possess more than 18yrs of progressive experience and am recognized for providing outstanding team leadership, building strategic industry partnerships, coordinating tactical plans, and devising proactive strategies while maintaining high quality standards within GxP/regulated environments.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Senior Director, QA Third Party Management

Eli Lilly (L@L) (Remote)
01.2023 - Current
  • Developed effective strategies for implementing supplier risk-based qualification and oversight processes, ensuring compliance with regulatory and company standards
  • Primary QA contact for third-party management process, ensuring risk-based qualification completion
  • Facilitated meetings between internal teams to ensure alignment on initiatives.
  • Implemented Governance and Oversight processes for third parties offering regulated services.
  • Developed and implemented strategic plans to maximize organizational efficiency, effectiveness, and profitability.
  • Built relationships with external partners, vendors, and customers in order to foster effective collaboration and governance.
  • Coordinate with stakeholders across multiple departments to develop innovative strategies for problem solving.
  • Provided guidance and oversight for quality management systems (e.g. TPM, change management, deviation management, document/records management etc.), in partnership with the business.
  • Promoted a culture of collaboration among staff members through regular communication, feedback, and recognition.
  • Evaluated training needs of employees based on job roles and responsibilities.
  • Maintained high standards in hiring staff; prioritizing flexibility, resourcefulness and drive.
  • Approve Third Party Management processes and system updates
  • Met with stakeholders to address issues and implement solutions.
  • Lead and/or support continuous ongoing improvement of the process
  • Directed the design of data analytics solutions for complex business challenges.
  • Supported and managed applicable inspection activities.
  • Reviewed and approved contracts for third-party vendors supporting regulated activities.

Associate Director, QA Third Party Management

Eli Lilly (L@L) (Remote)
08.2021 - 12.2022
  • Led GxP Third-Party Supplier Risk-Based qualification and oversight processes, including related systems and procedures.
  • Led due diligence activities in QA unit to identify issues and determine the need for further investigations to ensure compliance and timely reviews
  • Successfully oversaw the entire lifecycle of the third party process and database from development to launch and ongoing maintenance.
  • Conducted comprehensive vendor risk assessments, facilitated meetings, and maintained regular correspondence with both internal and external stakeholders to ensure diligent vetting prior to vendor activation.
  • Established and grew relationships with customers and industry partners to shape technical requirements and acquisition strategies.
  • Cultivated and maintained relationships to promote positive work culture.
  • Developed and implemented strategies to increase organizational effectiveness and efficiency.
  • Provided guidance and support to staff in order to maximize their performance.
  • Ensured compliance with all applicable laws, regulations and policies related to the organization's operations.
  • Support department leads with determining oversight and ongoing monitoring activities for third parties (suppliers)
  • Lead and/or support continuous ongoing improvement of the process
  • Provided support and management for inspections.
  • Maintained positive relationships with stakeholders by responding promptly to inquiries, requests and complaints.
  • Created effective communication channels between different departments in order to facilitate collaboration.
  • Managed recruitment process for new employees including conducting interviews, evaluating resumes, making job offers.
  • Assisted senior leadership team in developing long-term strategic plans for the organization.
  • Implemented innovative solutions for difficult problems encountered by the department.
  • Established and grew relationships with customers and industry partners to shape technical requirements and acquisition strategies.

Assistant Director, Quality Assurance & Compliance

Ionis Pharmaceuticals (Carlsbad, CA)
04.2020 - 08.2021
  • Developed, implemented, and maintained the Risk Management Program, integrating risk-based Vendor GxP and GMP
  • Ensured quality and compliance of nonclinical and clinical activities by adhering to internal procedures, FDA, ICH, and EU regulations.
  • Develop, plan, lead and facilitate governance at both operational and executive levels. Create governance charters, quality agreements, agendas, manage decision and action logs as well as issue logs.
  • Led/co-led continuous process improvement projects with GxP teams to enhance QMS efficiency throughout the GxP QMS.
  • Developed, implemented, and maintained a risk-based vendor management and oversight program
  • Designed vendor assessment tool to automate the evaluation of vendor criticality and risk/severity scores
  • Conducted continuous evaluations of vendors' risk profiles, proactively identifying and resolving any issues.
  • Collaborate with functional areas and vendors to define and develop meaningful KPIs to capture and report oversight activities
  • Partner with internal stakeholders to ensure potential and/or current non-clinical and clinical contracted vendors have adequate oversight
  • Serve as a point of contact for issue escalation and resolution
  • Create and track milestones/timelines and deliverables
  • Develop and lead the risk management program (formulate strategies, principles, methods and tools, and document in appropriate policies, procedures, and reports)
  • Collaborated, engaged, and educated cross-functional team members on risk identification, assessments, prioritization, mitigation control, and reporting processes.
  • Developed RACT and Risk Management Plan templates
  • Facilitated cross functional improvement discussions, including dashboard creation, metric development, and reporting.
  • Developed, implemented, and maintained risk-based audit program for 3rd party service providers / vendors.
  • Automated the assessment process and audit frequency by designing a risk-based audit RACT tool that considers various factors like risk, priority, criticality rating, and last audit date.
  • Designed, published, and managed the annual audit schedule for vendor, site, and internal process audits
  • Prepare and conduct qualification and routine audits, report findings, and write audit reports for technical vendor services
  • Review audit responses, CAPA’s and root cause analysis, and ensure timely closure and effectiveness checks
  • Review potential deviations and support investigations as applicable.

Manager, R&D Quality & Risk Management

ACADIA Pharmaceuticals (San Diego, CA)
06.2018 - 04.2020
  • Responsible for the development and continuous improvement of quality and risk management activities within R&D
  • Manage, host, and lead ongoing collaboration, engagement, and education discussion with cross-functional team members in the compliance of risk identification, assessments, scoring/prioritization, mitigations, gap analysis, trend analysis, and risk reporting in accordance with industry and company requirements
  • Co-lead and implement risk management strategies per ICH E6 Rev 2
  • Develop and report KPI, KQI Metrics and manage ongoing CSP metric reporting requirements
  • Support Data Integrity processes to include ALCOA principles
  • Partner with cross-functional colleagues to meet compliance requirements and business needs
  • Identify, develop, lead, and implement continuous improvement projects
  • Participate in vendor management activities (i.e., compliance, performance oversight, and risk management strategies)
  • Contribute to inspection readiness activities (i.e., process improvements, mock inspections, process flow, technology review and implementation)
  • Manage Site and Vendor Non-Compliance and CAPA oversight
  • Support mock inspections
  • Review vendor audit reports and SOWs to ensure oversight activities are implemented
  • Manage the review and revision of controlled documentation and ensure compliance across R&D functional groups
  • Supervise and mentor junior staff as assigned and provide performance evaluation input.

Global Project Manager

IQVIA (Remote)
11.2012 - 06.2018
  • Primary point of contact for Phase I, II, and III Global Trials, and act as primary liaison between Sponsor, Clinical Operations, Central Laboratories, Trial Management Materials, QA, and Scientific Teams
  • Host Internal and External team meetings with the sponsor, operations, and applicable study team leads to ensure management of risks and actions are followed through to completion and/or addressed in a timely manner
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the TMF filing, maintenance, and archival procedures for specified projects
  • Facilitate risk management meetings and discussions with internal teams and ensure mitigation action closure
  • Administer study training to sites, CRAs, and establish regular lines of communication with sites to manage on-going project expectations and issues
  • Develop, relay, implement, and manage protocol specific Study Plans, Action Logs, Risk Management/Mitigation
  • Assist with governance meeting content and discussions around budget, forecasting, and cost containment measures
  • Review key study quality metrics (i.e., surveys, logistics, database design (configurations and programming) etc.) and determine appropriate action in conjunction with study team
  • Assures that all aspects of projects are performed in compliance with standard operating procedures (SOPs), client SOPs (if applicable), and International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines, federal regulations and local laws where applicable
  • Participate in external and internal audits as required.

Global Project Manager (Systems)

IQVIA (Remote)
09.2012 - 11.2017
  • Point of contact for Global and Regional projects to ensure thorough computer system set up activities were conducted and validated (e.g., LIMS, TMS, Mobile Apps, etc.) for material release to investigator sites and study conduct activities
  • Develop and maintain the trial specific database design requirements thought the lifecycle of the project and develop and maintain client design standards and specifications per GCP, CAP, GLP, SOP and Sponsor requirements
  • As required, prepare and present study-specific materials and services at Investigator and Kick-off
  • Provide additional training to sponsor, CRO, and site personnel as required
  • Responsible for updates to the project tracking database, action/issues logs, risk logs, status sheets, Quality Incidents (QI’s), closure to CAPA’s, and management of timelines
  • Facilitate risk management meetings (identification, review and assessment, mitigation actions)
  • Ensure that the project team is trained on protocol requirements, and ensure Design Specifications are translated and implemented into the trial database systems
  • Provide scientific and technical advice to ensure delivery to the external customer and measure satisfaction
  • Perform and initiate QC review, approve PQ verifications
  • Monitor the overall study progress daily to ensure timelines are met and the study launch is successful
  • Manage the project specific budget for set up - start up activities, and coordinate change order activities
  • Participate in external and internal audits as required.

Quality Assurance Manager

Micromeritics – Pharmaceutical Services (Norcross, GA)
11.2006 - 09.2012
  • Assured consistent quality of production by developing and enforcing ISO17025 and cGLP systems, validating processes, and managing documentation
  • Study and interpret new and current compliance procedures and regulatory enforcement trends
  • Identify gaps in procedures, system and documentation against established industry benchmarks
  • Identify areas of potential operational improvements and communicate with internal customer value-added suggestions for achieving compliance
  • Create & Manage internal compliance quality systems based on regulatory Inspection Policies (e.g., general cGMP/GLP, ISO 17025) to include: development of audit plans, conducting internal and external quality audits, preparation of audit reports, documentation control, SOP development, deviation management, instrument OOS / OOT management
  • Develop, Coordinate, and conduct regular and ongoing compliance/quality/technical training
  • Evaluate and track corrective and preventive action responses in accordance with Corrective Action Preventative Action (CAPA) protocol, and assist lab management in the CAPA process through audit analysis
  • Assist in facilitation of external regulatory inspections (FDA, DEA, etc.)
  • Responsible for maintaining and updating regulatory licenses and registrations for state and federal compliance
  • Validation of instrument hardware to include review and approval of Instrumentation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Develop and implement validation protocol and procedures for computer systems validation to include procedure development (Test Protocol, Test Matrix, Test Summary, Test Case, Test Scripts, Approvals etc
  • Risk Assessment, Script initiation, Record keeping, End of Cycle archival.), Testing processes through each developmental stage, and data review and approval.

Education

Associate Degree of Science: Chemistry -

Augusta State University
05.2003

Skills

  • Vendor Management & Oversight (Identification, Selection, Qualification,Onboarding, Monitoring)
  • Vendor/Supplier Governance Program Lead
  • Risk Management Program (Development, Implementation, Training and Oversight)
  • Audit Program Development and Management
  • Ongoing Process Improvement Initiatives
  • Inspection Readiness
  • Metrics Development and Reporting
  • Project Management
  • FDA, ICH Guidelines
  • SDL (System Development Lifecycle) / Computer Systems Validations
  • Quality Management Systems (Quality Manual, Change Control, Deviation, CAPA, Records Management, Document Control, etc)
  • Team building and cross functional leadership
  • Staff Management and Development
  • Operations Management
  • Key Performance Indicators
  • Data Analytics
  • Human Resources Management
  • Team Management
  • Policy Implementation
  • Contract Management (Reviews, Approvals, etc)
  • Budget Control
  • Project Coordination
  • Cross-functional team leadership
  • Information Technology Management
  • Issue Management
  • Hiring and Retention
  • Verbal and written communication
  • People Management
  • Creativity and Innovation

Certification

Good Clinical Practice (GCP) – Barnette Certification, 2014

Clinical Summary

Phase I to IV, CNS, Rare Disease, Immunology, Cardiology, Infectious Disease, Oncology, Arthritis, Cardiovascular Disease, Hypertensive Disorder, Hyperlipidemia, Influenza, Non-Small Cell Lung Cancer, Malignant Tumor of the Ovary, Parkinson’s Disease, Depression, Dementia

Working Knowledge: FDA (cGMP, cGLP, GCP, and DEA Requirements: 21CFR 210/211/314, 11, 58, 820), ICH E6 Rev 2, ISO17025, ISO 9001, TMS (LTMS/CTMS), eTMF, Quality Docs (Veeva Vault), ACE, Microsoft Office, SharePoint, Aravo, Coupa, Concur

Affiliations

  • Lead Mentorship
  • Volunteering (e.g, Disaster Relief, etc.)
  • Health Coaching

Accomplishments

  • Awarded for Acceleration during regulatory Inspections 2023
  • Awarded for 'Resilience' during process design and implementation project.
  • Recognized for 'Delivering' to achieve organizational goals.
  • Advanced from Associate Director to Senior Director within first two years of employment.

Timeline

Senior Director, QA Third Party Management

Eli Lilly (L@L) (Remote)
01.2023 - Current

Associate Director, QA Third Party Management

Eli Lilly (L@L) (Remote)
08.2021 - 12.2022

Assistant Director, Quality Assurance & Compliance

Ionis Pharmaceuticals (Carlsbad, CA)
04.2020 - 08.2021

Manager, R&D Quality & Risk Management

ACADIA Pharmaceuticals (San Diego, CA)
06.2018 - 04.2020

Global Project Manager

IQVIA (Remote)
11.2012 - 06.2018

Global Project Manager (Systems)

IQVIA (Remote)
09.2012 - 11.2017

Quality Assurance Manager

Micromeritics – Pharmaceutical Services (Norcross, GA)
11.2006 - 09.2012

Associate Degree of Science: Chemistry -

Augusta State University

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Shanita Jones