Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sarah Volden

Santa Cruz,CA

Summary

Experienced global healthcare compliance and ethics leader focused on strategic risk management through strong business partnerships and in depth industry knowledge. Recognized for developing pragmatic solutions that streamline guidance necessary to meet regulatory requirements in a manner that assures quality and fidelity to standards without inserting excess bureaucracy.

Proven record of guiding compliance programs through complex environments, leveraging 17 years of global pharmaceutical, biotech, medical device, and digital health industry and compliance experience. Known for strong communication, collaboration, and cross functional leadership.

Overview

17
17
years of professional experience

Work History

Compliance Program Manager

Verily Life Sciences
South San Francisco, CA
11.2019 - Current

Oversaw and owned all elements of the Verily compliance program through various phases of maturity.

  • Strategic Advisor and Risk Management Across a Wide Product Portfolio: Provided compliance guidance in absence of comprehensive compliance policies to various Verily businesses which included products ranging from medical devices, AI/ML programming, to a CLIA lab and insurance company.
  • Relationship and Solution Oriented: Collaborated effectively with Alphabet, Google, joint ventures, and subsidiaries as well as functions such as Law, Regulatory, Quality, Medical, HR, Product, AI/ML Data Science, Medical Devices, Tech, and User Research.

Manager, Pharmaceutical and Life Sciences Advisory

PricewaterhouseCoopers
Los Angeles, CA
07.2007 - 06.2019

Advised over 25 pharmaceutical, biotech and medical device companies on global compliance programs to assist chief compliance officers (CCOs) in mitigating and managing regulatory and compliance risk.

  • Risk Assessments and Program Design: Assisted CCOs in assessing and defining their compliance program strategy and roadmap.
  • Corporate Integrity Agreement (CIA) preparedness services: Prepared companies for CIAs through mock IROs and program and process redesign.
  • Global Expertise and Leadership: Recruited to Switzerland to build a virtually ground-up network of pharmaceutical and life science healthcare compliance specialists across multiple European markets. During successful two-year assignment, was awarded promotion to Senior Manager (PwC Switzerland)
  • Team Leadership: Managed teams ranging in size from 2 to over 15 people. Mentored over 20 individuals formally and informally

Education

Bachelor of Science - Computer Science And Engineering

University of California - Los Angeles
Los Angeles, CA
06-2007

Skills

  • Internal Controls
  • Audit management
  • Compliance Monitoring
  • Environmental Compliance

Timeline

Compliance Program Manager

Verily Life Sciences
11.2019 - Current

Manager, Pharmaceutical and Life Sciences Advisory

PricewaterhouseCoopers
07.2007 - 06.2019

Bachelor of Science - Computer Science And Engineering

University of California - Los Angeles
Sarah Volden