Senior Compliance Manager

Roche • South San Francisco, CA

23h • Onsite

About The Position

Senior Compliance Manager Strategic Mission The mission of Medical Operations Quality & Compliance (MedOps Q&C) is to be the best-in-class Local Quality organization that enables and empowers the U.S. Affiliate to do what’s right for patients by guiding the business through the medical quality and compliance and healthcare compliance landscape. We achieve this by leveraging our unique business, medical quality and compliance knowledge and fostering broad enterprise collaboration with key organizational partners to navigate the regulatory landscape while promoting a culture of quality and compliance. The Opportunity The Senior Compliance Manager is a specialized strategic advisor and key contributor within the MedOps Q&C team. This individual possesses in-depth specialist knowledge of the compliance discipline and broad knowledge of related regulatory areas. This highly cross-functional role provides high-impact guidance across medical (GCP, GVP, MDR, IVD) and healthcare compliance, ensuring the U.S. Affiliate meets its business objectives through agile risk management. By participating in large global/local cross-functional teams, this role is expected to navigate complex situations by identifying risks and applying a diverse skillset, including coaching colleagues to help develop their expertise and skills. Focus: MAP/DiCELA Governance Operational governance and oversight role responsible for ensuring Market Research and Patient Support Programs (MAPs) and Digital Customer Engagement and Listening Activities (DiCELA) are initiated, executed, and tracked according to quality standards. Serves as the ultimate accountability holder for proactively identifying, mitigating, and escalating critical compliance risks related to MAP and DiCELA activities to Senior Management.

Requirements

• Bachelor’s Degree required in Life Sciences or other relevant technical disciplines; advanced degree in life sciences or other relevant technical disciplines strongly preferred
• 7+ years of multi-disciplinary experience in the biotechnology / pharmaceutical industry
• 5+ of experience in working with medical compliance principles, guidelines and regulations
• Previous work-experience gained at Genentech, preferably in Medical Affairs or another compliance-related function, is strongly preferred
• This position is based in South San Francisco, CA and relocation benefits are not available for this posting.

Responsibilities

• Provides compliance subject matter expertise to U.S. Medical and the U.S. Affiliate, both proactively and in response to inquiries.
• Represents U.S. Medical/U.S. Affiliate at a global level to ensure the U.S. perspective is taken into account in strategic and process decisions.
• Navigates complex situations by identifying risks and influencing the business in developing risk mitigation strategies, applying a diverse skillset.
• Serves as the ultimate accountability holder for proactively identifying, mitigating, and escalating critical compliance risks related to MAP and DiCELA activities to Senior Management.
• Acts as a subject matter expert for contracting compliance within U.S. Medical.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees