Supervisor, Quality Systems (Record and Document Management) #3262
People & HR, Operations, Quality Assurance
Menlo Park, CA, USA
Posted on Monday, September 25, 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.
As part of the Quality, Regulatory, and Clinical Quality Assurance (QRC) organization, the Record and Document Management Supervisor, MPK will be responsible for day to day scheduling and execution of GRAIL’s Document Management program by combining an understanding of quality processes and dedication to excellent internal customer service. This position will report to the Associate Director, Record and Document Management, Systems, and Education (RDE). This is a hybrid role, based in our Menlo Park, California Corporate offices, requiring onsite 2 days a week and additionally on an as-needed basis. This is a hands-on role with some supervisory responsibilities.
- Contribute to the implementation and design of GRAIL’s document management system program for cross-functional, localized, and other corporate quality initiatives.
- Execute company policies and procedures in support of ISO13485, CAP/CLIA, NYSDOH, and FDA, in collaboration with key stakeholders.
- Participate in creation of the product roadmap and risk assessment strategy for GRAIL’s electronic document management system (eDMS), including supporting computer system validation (CSV) efforts, as needed.
- Provide quality guidance and direction on cross-functional teams throughout the record and document management process to ensure that product and customer requirements are met.
- Schedule and execute change management workflows (change control, drafting, collaboration, review, approval, training assignment creation/impact assessment, controlled copy, and periodic review) to ensure compliance with GDP and regulatory requirements.
- Investigate and resolve quality management system issues with cross-functional teams utilizing root cause analysis; promote continuous education for cross-functional teams regarding the document management system.
- Ensure training of self and of the team is completed on-time.
- Maintain quality records (hard copy file room and electronic storage) in support of ISO13485, CAP/CLIA, NYSDOH, and FDA, in collaboration with key stakeholders.
- Support inspection readiness strategy and procedures for the MPK site, including documentation, training materials, and other resources; provide support for internal and external audits, as needed.
- Generate data for key performance indicators (KPIs), metrics, and trends; work with the RDE team to identify and implement improvement projects.
- Supervise Quality Specialists and Coordinators via coaching, encouragement, and evaluation to ensure quality and company objectives are met.
- Provide input to the RDE budget; contribute to achieving financial objectives.
Your background and qualifications will include:
- Bachelor’s degree in a scientific or related field required.
- 5-8+ years of quality experience working in a biotechnology, healthcare, or other regulated environment.
- Previous supervisory experience preferred.
- Previous experience as an electronic document management system (eDMS) administrator
- 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, CAP/CLIA/NYSDOH, and ICH/GCP preferred.
- Clear ability to work well under pressure with a proactive approach, including managing multiple priorities, deliverables, and deadlines.
- Results-driven and solution-oriented with 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 and time management skills.
The expected, full-time, annual base pay scale for this position is $99,000 - $124,000
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 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.