The Associate Director, Safety & Data Integrity Operations will partner with the Head of Safety, & Data Integrity Officer to develop and deploy a robust Safety & Data Integrity program at GRAIL. The Associate Director will work cross-functionally to implement Safety & DI strategy; prepare the program overview and education, collaborate on deployment of policies into functional SOPs, setup governance structure, and build infrastructure to operationalize the programs.

This position is based in Menlo Park, California and will be working in the office on a hybrid basis two days a week.

Responsibilities:

• Develop, Implement, and Continuous Improvement of Safety and Data Integrity Policy, and procedures to ensure compliance with regulatory requirements and best practices

• Conduct regular assessments to identify potential risk areas, and areas of improvement

• Collaborate to build lead training sessions to promote awareness and adherence to Safety & Data Integrity guidelines

• Collaborate with cross-functional teams to integrate safety and data integrity into all aspects of GxP systems and processes.

• Stay informed about emerging safety trends, and technologies to proactively identify opportunities for enhancing safety and data integrity programs and practices.

• Build a central repository of safety events, and create periodic reports to identify trends, and signals.

• Define, create, and communicate metrics for Safety & Data Integrity, and establish governing mechanisms for periodic monitoring and communication.

• Work with Complaint Handling, MSL, and other functions on triaging of safety related complaints, and appropriate regulatory reporting.

• Manage investigation and analysis of incidents and near misses to identify root cause and develop corrective and preventive actions.

• Foster a culture of safety by promoting open communication, employee engagement, and accountability of safety and data integrity.

Preferred Qualifications:

• B.S./B.A. in a science or related life science field; advanced scientific degree desired.

• 10 + years experience in any of the following industries (preferred): direct In Vitro Diagnostic, medical device or pharma industry.

• Experience in building programs from ground up, and setting up governance and building infrastructure to operationalize.

• Familiarity with Quality Management Systems in medical devices, life sciences industry and understanding of safety risk management, and GxP compliance.

• Work with data to create trending reports, and identify potential signals.

• Lead and drive continuous improvement (training in lean sigma, six sigma preferred)

• Demonstrated ability to initiate process improvements and take initiative.

• Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment.

• Ability to drive and manage change with a positive approach.

• Potential travel of up to 10%

The expected, full-time, annual base pay scale for this position is $159,000 - $199,000

Actual base pay will consider skills, experience, and location.

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 (https://grail.com/about/#contact-us) to request accommodation. GRAIL maintains a drug-free workplace.