Senior Compliance Manager

Roche • South San Francisco, CA

2d • $138,300 - $256,800 • Onsite

About The Position

The Senior Compliance Manager is a specialized strategic advisor and key contributor within the Medical Operations Quality & Compliance (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. The focus is on Market Research and Patient Support Programs (MAPs) and Digital Customer Engagement and Listening Activities (DiCELA) governance and operational oversight, ensuring these activities are initiated, executed, and tracked according to quality standards. This role 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 any discipline; Life Sciences or other relevant technical disciplines preferred.
• 7+ years of multi-disciplinary experience in the biotechnology / pharmaceutical industry
• 5+ of experience in working with medical compliance principles, guidelines and regulations

Nice To Haves

• Advanced degree in Life Sciences or other relevant technical disciplines strongly preferred.
• Previous work-experience gained at Genentech, preferably in Medical Affairs or another compliance-related function, is strongly preferred.

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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior