Senior Quality Systems Engineer # 4465

BioSpace; Menlo Park (CA); On-site; USD 109,000 - 136,000; Full time

Benefits offered by this job

Flexible work arrangements

401(k) retirement plan with employer match

Comprehensive health coverage

Mindfulness programs

Job summary

A healthcare company is seeking a Senior Quality Systems Specialist in Menlo Park, California. The role focuses on maintaining and improving GRAIL's Records and Document Management. Candidates must have a bachelor's degree and 5+ years of quality management experience, preferably with document management insights. The position offers flexible work arrangements, with a compensation range of $109,000 to $136,000, plus benefits. Join a team working towards redefining cancer care!

Qualifications

• 5+ years of experience in quality management, particularly in Document Management.
• Proven leadership abilities in regulatory activities.
• Must handle conflict and ambiguity effectively.

Responsibilities

• Oversee compliance with FDA and ISO regulations.
• Lead improvements for the electronic Quality Management System.
• Create educational presentations on change management.

Skills

Quality Management

Document Management

Regulatory Compliance

Interpersonal Skills

Project Management

Analytical Skills

Education

Bachelor’s degree

Tools

Veeva Vault

Microsoft Office

Google Suite

Jira

Zoom

Job description

Overview

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 the bay area of 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

Role and Location

As part of the Compliance, Operations, Records, and Education (C.O.R.E.) organization, the Senior 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 is based in Menlo Park, California, and will move to Sunnyvale, California, in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.

Responsibilities

• 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.
• 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.
• 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.

Required Qualifications

• Bachelor’s degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience.
• 5+ years 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.
• Requires exceptional interpersonal, verbal, and written communication skills in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to be flexible.
• Demonstrated project management experience developing processes and leading their implementation in a cross-functional environment.
• Ability to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation.
• Ability to deal with frequent change, delays, or unexpected events.
• Experience with auditing and experience representing and responding to regulatory agency audits.

Preferred Qualifications

• Proficiency with standard office software applications including Microsoft Office, Google Suite, Jira, and Zoom
• Working experience in technical writing is appreciated.

Compensation and Benefits

The expected, full-time, annual base pay scale for this position is $109,000 - 136,000 for Menlo Park, CA. Actual base pay will consider skills, experience, and location.

This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.

Equal Employment Opportunity

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!