Staff Quality Systems Specialist - Records, Document Management, Systems & Education #4348

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in Menlo Park, California, 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 grail.com.

As part of the Compliance, Operations, Records, and Education (C.O.R.E.) organization, the Quality Systems Specialist will be responsible for supporting the maintenance, delivery, and continuous improvement of GRAIL’s Records and Document Management, Systems, and Education-  with an emphasis on the electronic Quality and Learning Management System (Veeva). This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. This role will be a hands-on resource reporting to the Director, Compliance, Operations, Records, and Education (C.O.R.E. Team)-  and will also require routine coordination of other cross-functional needs and initiatives with other Quality colleagues, business stakeholders, and leadership team members.

This role must be able to work on-site from GRAIL’s Durham, NC facility approximately 3 days a week.

• Ensure compliance with company processes and procedures, as well as applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines.
• Responsible for the oversight and continuous improvement of efficient, effective, and compliant processes supporting GRAIL’s electronic Quality Management System (eQMS) and Learning Management System.
• Lead continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control, Change Control, and Quality Training.
• Maintain program user requirements and develop comprehensive validation test protocols.
• Create and lead educational presentations on change management programs (new hire, process updates, etc.)
• Maintain controlled documents, track document change management processes, and edit documents to ensure formatting, legibility, completeness, and adherence to GRAIL’s controlled templates, procedures, and other relevant processes.
• Coordinate the review, approval, and archival of GRAIL’s controlled documents in accordance with strict timelines as well as internal policies and regulations.
• Collaborate and provide mentorship to change owners, approvers, and cross-functional owners, ensuring effective implementation of change. Call out areas of non-compliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies.
• Respond to all inbound document-related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies.
• Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps.  
• Generate data for key performance indicators (KPIs)/metrics for management reviews.Provide document control support for internal and external audits and inspections.
• Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system implementations and updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience, as needed.
• Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants. Understand the interrelationships of different disciplines and how these connections can be used to improve Document Control processes. 
• Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Resolve a wide range of issues in creative but compliant ways and suggest variations in approach. 

• Bachelor’s degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience.
• 8+ years of related experience (Masters & 5+ years of related experience) of experience performing a quality management function, preferably with experience in Document and Records Management.
• Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485 Quality System, CAP/CLIA, NYS, ISO 15189, ISO 13485, IVDR, and other applicable industry requirements.
• Experience using an eDMS required; Veeva Vault highly preferred.
• Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.

Expected full time annual base pay scale for this position is $114K - $142K. 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.