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.

The Manager/Sr. Manager Clinical Compliance leads strategy, implementation, and the roll-out of business processes in clinical development. This will require a thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. This person will also assist in the coordination of the clinical audit program, track audit and CAPA commitments, in addition to providing basic guidance on constructing adequate responses. A strong history of leadership and demonstrable success in working in cross functional teams is required. 

You Will:

• Lead implementation, and roll-out of Business Process Development or Improvement for Clinical Operations and Clinical Contracts and Finance.
• Contribute to development of departmental and cross-functional Standard Operating Procedures, Work Instructions, and Process Manuals.
• Develop effective process workflows to streamline process.
• Assist in the coordination of clinical audit program.
• Track and follow-up on audit and CAPA commitments to closure.
• Provide assistance to functional areas in constructing robust CAPAs and audit responses.
• Assist in identification of process gaps or areas of process improvement and find efficient and scalable solutions.
• Work with multi-functional groups to define cross-functional roles and responsibilities.

Your Background Should Include:

• A Bachelor’s degree with an advanced degree preferred.
• Ideal candidates will have 8+ years of relevant experience, 3+ years experience developing SOPs in a GCP environment.
• Some experience in management of GxP CAPAs is desired.
• Primary lead on multiple process improvement projects.
• A proven ability to work cross-functionally to successfully implement process improvements.
• Experience leading change management efforts.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.