Quality Systems Specialist (Change Management) Durham, NC #2538

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 organization, the Quality Systems Specialist will be responsible for supporting the maintenance, delivery, and continuous improvement of GRAIL’s Quality Systems with an emphasis on the electronic Change Management System. 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 Manager, Quality Systems 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 but must be able to work on-site from GRAIL’s Durham, NC facility approximately 3 days a week.
You will:

• 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).
• Support continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control and Change Control.
• 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, and provide company training 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.

Your qualifications and background will include:

• Bachelor’s degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience.
• Minimum of 3 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 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 are essential 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.
• Proficiency with standard office software applications including Microsoft Office, Google Suite, and Zoom

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.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.