Associate Director, Quality Systems Training & Document Management #3316
Menlo Park, CA, USA
Posted on Wednesday, November 1, 2023
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 www.grail.com.
We are seeking a highly motivated hands-on manager to join us as an AD, of Quality Systems Training and Document Management. This position is responsible for the execution and effectiveness of Quality Management Training as well as Document Management responsibilities. This role will work in accordance with the GRAIL Quality Management Systems Regulatory and Compliance standards.
- Design and Implement Training Strategies:
- Develop and assess quality training strategies to support business initiatives and enhance organizational effectiveness.
- Modify existing policies and processes, and integrate materials with the Learning Management System (LMS).
- Client and System Support:
- Serve as the first point of contact for internal clients regarding performance, training issues, and curricula changes.
- Troubleshoot systems issues and oversee the administration of the LMS.
- Content Development and Management:
- Create and update instructional materials, SOPs, on-the-job training, and ensure content aligns with compliance standards.
- Lead the internal training counsel to inform employees of ongoing training initiatives.
- Training Delivery and Evaluation:
- Conduct Train-the-Trainer and Instructor-Led Training classes.
- Evaluate training efficiency through metrics collection and analysis, ensuring alignment with strategic business goals.
- Compliance and Standardization:
- Work with audit response teams to address audit findings and ensure training content is current and compliant.
- Drive training standardization to enhance effectiveness and readiness for future business needs.
- Project and Records Management:
- Lead training initiatives, including design, development, and delivery, to drive continuous improvement and efficiencies.
- Assist the records management team as required, ensuring organized and efficient processing.
Your qualifications and background should include:
- Bachelor’s degree with 12 years experience, preferably in Life Sciences
- Minimum 5 years training and development experience experience in GCP Records Management preferred
- Familiarity with Veeva Vault QMS, eTMF, Google and MAC products preferred
- Ability to perform and interpret needs analyses, and translate the findings into actionable next steps.
- Inspection readiness mindset required
- Proven analytical statistical, quantitative, and deduction skills and ability to make qualitative judgments of training, education, and development resources in all types and formats.
- Thorough knowledge of learning concepts, training, and development methods and techniques.
- Ability to multitask and work cross functionally within the team on multiple projects simultaneously
- Knowledge of adult learning processes, instructional design techniques, and evaluation methodologies.
- Exceptional planning, prioritizing and project management skills and the ability to apply these skills in effective working partnerships across organizational lines and multiple initiative in a project management style
- Excellent oral/written communication skills, including group facilitation and presentation skills.
- Excellent interpersonal skills, including leadership, influencing, and relationship-building across functions. Ability to identify, use, understand, and manage emotions in positive ways to empathize with others, overcome challenges, and defuse conflict, self-awareness.
- Familiar with technical writing capabilities
- Knowledge of Veeva Vault Quality Management System platform
- Knowledgeable in applicable regulations-GXP, ISO 13485:2016, ISO 15189, 21 CFR Part 820, 21 CFR Part 493 (CLIA), CAP, Part 11 (Document Control)
- New York State Department of Health (NYSDOH) preferred but not required.
- Practice GDP for both electronic and paper documents
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 Office and Affirmative Action 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.