- Provide system guidance and direction on cross-functional teams throughout the development cycle and identify/coordinate cross-functional deliverables for submissions to ensure that product and customer requirements are met.
- Serve as internal client's first point of contact for system change request
- Work closely with internal clients to gain understanding of system change plansImplement new feature integrations
- Test the impact of new features before release
- Monitor system performance
- Execute Quality Review to ensure that records and quality events align with GDP and regulatory requirements and initiate risk-based assessment and audits to ensure compliance with current standards and resolution of issues alongside key partners.
- Support the product roadmap and risk assessment strategy for GRAIL's electronic quality management system (eQMS) and learning management system (LMS), including supporting computer system validation (CSV) efforts, as needed.
- Manage generation of management reports including key performance indicators (KPIs), metrics, and trends; work with partners to identify and implement improvement projects.
- Manage Quality Management System and Learning Management System vendor relationships and accounts, as assigned, providing cross-functional subject matter expertise.
- Lead Quality Systems Specialists and Coordinators via coaching, encouragement, and evaluation to ensure quality and company objectives are met.
- Ability to troubleshoot issues quickly and effectively
- BS / MS in Computer Science or related degree or equivalent
- 8+ years of experience working in a biotechnology, healthcare, or other regulated environment.
- Proven background in quality procedures, processes, and guidelines, and the ability to interpret and operationalize quality system regulations.
- Experience with the following: 21 CFR 820, ISO 13485, IVDR, CAP/CLIA/NYSDOH, and ICH/GCP and GXP preferred.
- Software and Query Tool ExperienceDatabase Servers: Oracle, SQL,Work DayClear ability to work well under pressure with a proactive approach, including managing multiple priorities, deliverables, and deadlines.
- Requires strong analytical skills and a passion for solving problems via collaboration and a growth mindset.
- Strong and effective written and oral communication skills across all levels of the organization, with a diverse group of individuals.
- Ability and passion to provide excellent internal and external customer service.
- Team-oriented approach with proven ability to quickly and consistently establish rapport and collaborate effectively with key stakeholders, cross-functional partners, and leadership.
- Excellent organization/communication and time management skills.
- Proficiency with standard office software applications including Google Suite, Microsoft Suite, Apple, and Zoom; prior electronic quality management system (eQMS) and experience using Veeva Vault QMS, LMS, TMF required. Veeva certifications preferred
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Staff Veeva Systems Solutions Specialist #3715 - Menlo Park, United States - GRAIL
Description
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit
As part of the Compliance Operations Records and Education team, the Staff Veeva System Specialist will be responsible for maintaining Veeva QMS and LMS systems. In this role you will be seen as the internal point of contact for Veeva systems changes and implementations to the system per request from internal users/stakeholders. This is a hybrid role and requires you to be onsite 2 days a week in Menlo Park, CA
Responsibilities:
Preferred Qualifications:
The expected, full-time, annual base pay scale for this position is $127,000 - $159,000
Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
