Director, Quality Systems
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
As a key member of the Quality Leadership Team, the Director , Quality Systems will be accountable with the overall leadership and implementation of GRAIL’s Global Document Management Program, Quality Training program, Records Management, designed to comply with applicable laws and regulations. In addition, He/She will drive deployment of an Electronic Quality Management System (eQMS) to support all GRAIL Quality Management Systems initiatives activities.
You will
- Overall globally owning and manage the document management and training business processes and the electronic systems supporting GxP documents and training needs, including (but not limited to) scaling business processes to match recent and future growth, developing and seeing through implementation of strategic plans and collaborating with global stakeholders to ensure that current and future processes and systems meet all user requirements
- Define Veeva Vault implementation priorities and operational execution roadmap of the entire Veeva Quality Suite by collecting and synthesizing input from external customers, cross-functional business partner, and GRAIL executive.
- Work with cross-functional teams from Engineering, Technology, Operations, QRA , and PMO to determine prioritization and resource allocation, determine process and system improvements, as well as communicate critical business needs and time requirements.
- Manage the configuration, daily administration, and monitoring Veeva Vault QualityDocs
- Responsible for the systematic control of all Quality related documents throughout their lifecycleResponsible to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements
- Manage and oversee EDMS, ensuring compliance with internal and Regulatory requirementsPartner with SOP authors/owners in other functional areas and assist in creating, revising, documents (SOPs, reports, protocols, specifications, etc.,) route for review and approval, issue effective SOPs and obsolete older SOPs; collaborate with other functional areas to establish training applicability for new or revised SOPs
- Responsible for managing the electronic archive of records in the EDMS in compliance with regulatory requirements.
- Collaborate with and educate GRAIL colleagues on electronic and paper archival of records
- Provide support during internal and external audits related to Regulatory and internal audits for good Documentation practices (Back-room activities)
- Establish and maintain procedures governing the lifecycle of procedural documents (e.g., Policies, Standard Operating Procedures (SOPs), work instructions) and other regulatory and administrative documents
- Collaboratively design and develop training curricula and assessments for the Quality organizationCollaboratively design and develop training on Quality and Good Documentation principles for the entire company
- Lead the strategic planning process for GRAIL’s Quality training program and is responsible for its implementation.
- Conduct training needs analysis and identifies performance gaps across assigned functions as required.
- Develop, implement, and maintain Learning Management systems (LMS), programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs), Good Clinical Practice (GCP), Good Documentation Practice (GDP) principles, ISO 13485, CAP, CLIA, NYSDOH, ISO 15189.
- Serve as subject matter expert on best practices and new state of the art training delivery methodologies and curriculum development.
- Manages and develop personnel, including organizing and prioritizing team deliverables,, training, writing performance reviews and guiding personnel in longer-term development.
You background will include:
- Minimum of a Bachelor’s/Master's degree in an area of life sciences.
- Minimum of 10 years of experience implementing, validating, maintaining and integrating electronic document and training systems in an FDA or equivalent regulated setting.
- Proven leadership skills with an ability to set a vision, to drive change, and to lead and mentor others.
- Excellent communication skills, highly competent presenter, able to gain credibility, engender trust and influence all levels, strong partnering skills, bias for action and tangible results.
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.