Years of professional experience
Jeremy Jones
Queen Creek,AZ
Summary
Results-driven Quality leader with expertise in biotech quality management and process excellence, focused on process management, documentation, and advancing data driven GxP practices across the industry. Seeking a dynamic role with the opportunity to drive innovation and ensure compliance while improving the patient experience and advancing a culture of quality. Proven ability to drive strategic initiatives, foster cross-functional collaboration, and provide high-level support to global Research & Development practices. Exceptional organizational, communication, and analytical skills with a commitment to transformative outcomes across R&D in the industry.
Overview
10
10
8
8
Years of people leadership
5
5
Years of biotech experience
Work History
Associate Director, Strategic Planning & Operations, Chief of Staff
Amgen Inc
Thousand Oaks, CA
11.2022 - Current
- Appointed as Chief of Staff to the Vice President of Research & Development Quality & Compliance, leading strategic initiatives, organizational development, and business operations.
- Responsibilities encompassed strategic planning, support to GxP governance, audit & inspection support, and GxP process improvement, along with the effective management of departmental calendar, budget, resources, metrics, and managing 3 team members
- Collaborated extensively with leaders across the organizational matrix to drive Amgen's strategic agenda and effectively manage quality and compliance across global research & development efforts.
- Engaged with industry experts, consultants, and consortiums and led transformative endeavors aimed at optimizing processes and technology across the biotechnology industry.
- Held pivotal roles on quality governance and advisory forums and led due diligence and post-acquisition assessment & integration of R&D activities.
Operations and Intelligence Officer
United States Army & Army Reserve
01.2015 - Current
- Progressively advanced through management positions in Intelligence, Operations, and Civil Affairs, leading complex operations and effectively managing/ training teams ranging from 9 to 40 personnel
- Handpicked for a pivotal leadership role as the principal staff officer overseeing personnel support and human resource management
- Managed all administrative processes, including strength management, personnel qualifications, succession planning, performance evaluations, assignments, and retention
- Led transformative process improvement initiatives that revolutionized the organization's evaluation report process, resulting in a remarkable 20% reduction in late/overdue reports, catapulting the unit to the top spot in readiness within the command
- Appointed as the Family Readiness Program Director, assuming direct responsibility for the creation and implementation of a groundbreaking program supporting over 180 personnel.
Manager, Business Process Management
Amgen Inc
Thousand Oaks, CA
10.2021 - 11.2022
- Entrusted with leading cross-functional continuous improvement and quality initiatives centered on process management, process excellence, and developing training that drives performance across clinical trials and pharmacovigilance processes.
- Conducted comprehensive assessments to evaluate the need for creating or revising business processes and associated documents.
- Determined project scope and scale while meticulously identifying potential impacts on CA/PA’s, regulatory commitments, and compliance.
- Played a pivotal role in supporting root cause analysis investigations for significant deviations and contributed to the meticulous preparation and execution of partner audits and regulatory agency inspections.
- Defined innovative business process management system solutions tailored to user and client needs, continually exploring opportunities for seamless integration with other components of the Quality Management System.
Senior Associate, Learning Operations
Amgen Inc
Thousand Oaks, CA
04.2020 - 10.2021
- Collaborated closely with senior management and key stakeholders across R&D to design and implement compliant and highly effective training strategies, ensuring alignment with the rigorous standards of GxP regulated environment for global clinical trials.
- Served as a valuable quality representative on project teams delivering strategic initiatives by driving functional streamlining efforts, improving R&D processes & procedures, and implementing of cutting-edge digital strategies.
Project Management Coordinator
Amgen Inc, CW
Thousand Oaks, CA
01.2019 - 11.2019
- Acted as a pivotal liaison between leaders across Amgen, overseeing the creation and refinement of critical business processes and controlled documents including SOPs, Work Instructions, FORMs, and Guides.
- Led multiple simultaneous projects and served as the lead facilitator for the Process Document Management team’s weekly forums.
Education
M.S in Management, Strategy, and Leadership -
Michigan State University
05.2022
B.S in Criminology & Criminal Justice -
California Lutheran University
05.2018
Certificate – Digital Leadership -
Cornell University
Skills
- GxP Quality & Compliance
- Process Documentation (SOPs, WIs, GDEs)
- Business Process Management
- Audit & Inspection Readiness
- Training & Development
- Quality Management Systems
- Process Excellence & Improvement
- Global Research & Development Regulations (IE GxP & ICH)
- Strategic Planning & Leadership
- Project Management
- Strategic Initiatives
- Business Operations & Strategy
- Post M&A Integration
- FP&A / Budgeting / Forecasting
- Organizational Development
- Human Resources
- Financial & Capital Management
Certification
- Six Boxes Performance Thinking Practitioner
- Amgen Lean Leadership Immersion Program
Volunteer Experience
- Steering Committee Member, IMPALA, 05/01/23, Present, Gained valuable experience in decision-making and collaboration processes through participation in steering committee made up of several member companies across the biotechnology & pharmaceutical industry. Drafted educational/promotional documents and developed project deliverables as an active member in industry work product teams to advance data analytics across the biotech industry.
- Board Member, Conejo Valley Recreation Advisory Council, 06/01/20, 06/01/22, Reviewed organization's programs and services to update and approve strategic plans. Oversaw implementation of new bylaws, policies and procedures to increase transparency and accountability. Formulated ideas from conception to implementation to increase community engagement in public parks and recreation.
- Advisory Board Member, Suzanne Manlet Foundation, 01/01/08, 01/01/16, Represented organization and promoted objectives at fundraising and community events. Engaged in fundraising efforts resulting in significant donations.
Accomplishments
- Steering Committee Member - IMPALA BioPharma Industry Consortium
- IMPALA Podcast Host - Advancing Quality & Data Analytics across GCP & GVP
Timeline
Associate Director, Strategic Planning & Operations, Chief of Staff
Amgen Inc
11.2022 - Current
Manager, Business Process Management
Amgen Inc
10.2021 - 11.2022
Senior Associate, Learning Operations
Amgen Inc
04.2020 - 10.2021
Project Management Coordinator
Amgen Inc, CW
01.2019 - 11.2019
Operations and Intelligence Officer
United States Army & Army Reserve
01.2015 - Current
M.S in Management, Strategy, and Leadership -
Michigan State University
B.S in Criminology & Criminal Justice -
California Lutheran University
Certificate – Digital Leadership -
Cornell University
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