Grail’s mission is to detect cancer early, when it can be cured
Director, Quality Operations
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 Director, Quality Operations, you will be responsible for establishing, executing, and overseeing Quality Operations for Manufacturing and Clinical Laboratory. Key responsibilities include but not limited to reagent manufacturing program, Quality control program Test method validation, Process validation, stability program, Equipment program, Change Control Program, and clinical laboratory management to ensure appropriate quality policy, regulatory obligations such as Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485:2016, CLIA, CAP, and New York State are implemented and followed company-wide.
- Work closely with R&D to understand new product designs and transform process knowledge into high throughput production methods for production and manufacturing.
- Collaborate with Product and R & D teams to evaluate product specifications, processing parameters and operational boundaries through collaboration during the development phase.
- Collaborate with Clinical Laboratory Operations, Automation, QC, QA, IT/Software, and Bioinformatics to develop, verify and validate all new processes, including reviewing/updating pFMEAs.
- Ensure compliance to CAP/CLIA, NYS requirements as the Laboratory develops, validates and performs Lab Developed Test assays.
- Provide direction and guidance to the Equipment Engineering team on Commissioning, Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various Clinical Laboratory, Facilities, manufacturing equipment.
- Collaborate with the manufacturing team to develop test plans, protocols, batch records, and reports to ensure designs and processes meet product specifications, regulatory requirements and standards.
- Oversee all aspects of tech transfer for new products including post-release QA.
- Identify, develop, recommend and implement efficiency initiatives associated with manufacturing and QC processes.
- Oversight of the batch review process, resolution of quality systems encountered while manufacturing and testing, and generation of disposition documentation to ensure timely release of materials.
- Responsible for the management of the batch release process and team.
- Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
- Review documents associated with deviations, investigations, OOS results, and CAPA action plans.
- Review and approve internal and external documentation, ensuring compliance with applicable cGMP regulations and industry guidelines.
- Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required.
- Identify issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.
- Engage in activities to continuously assess and improve Lot Review and Disposition processes.
- Support the development, implementation, and revision of corporate quality systems.
- Develop continuous improvement strategy which aligns to the business strategy and operational strategy while taking into account present operational realities.
- Serve as subject matter expert for the change control process, requirements, including departmental metrics reporting and trending.
- Work with functional area representatives or responsible change owners to develop change management strategies and prepare documented plans including assessments, readiness, and timelines.
- Facilitate change control activities with cross-functional stakeholders to create schedules and monitor the deliverables against the timeline.
- Develop departmental standards and guidelines for change control inputs and requirements needed to support change control packets.
- Provide management reports on change management process progress.
- Hiring, managing, developing, retaining, coaching and mentoring staff including setting individual and team goals and conducting performance reviews.
Your Background Should Include:
- BA/BS and a minimum of 10+ years in Quality Assurance experience.
- Demonstrate working knowledge of: Facilities Validation, Equipment Validation, Process Validation, Computer Validation, and Operational Excellence.
- Strong experience in FMEAs, Lean/Six Sigma projects, process validation, process capability, statistical analysis and application of statistical methods.
- Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and quality leadership.
- Experience with managing contract manufacturing and/or testing organizations, including quality agreement negotiation.
- Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
- Solid understanding and experience with product lot disposition, investigations, change control, and process qualification and validation.
- Ability to communicate above and below level in a way that fosters positive relationship building.
- Strong knowledge of GxP regulations, quality systems, and regulatory guidance documents in US and EU.
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Demonstrated project management skills.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
- Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines.
Complete health coverage
Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
On site amenities
Stay healthy, happy and productive with our gym facilities, and daily catered lunches and snacks for all.
Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
We offer competitive salaries and savings plans to provide peace of mind for long-term financial planning.
GRAIL at a glance
GRAIL focuses on Biotechnology, Life Sciences, Healthcare, Diagnostics, and Medical Technologies. Their company has offices in Menlo Park. They have a large team that's between 201-500 employees. To date, GRAIL has raised $3.605B of funding; their latest round was closed on May 2020.