Biotech jobs in United States

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The OneRoche Governance & Medical Compliance Chapter is responsible for operating the OneRoche Governance & Medical Compliance Framework to safeguard patients, reflecting the legal accountability of Roche's Chief Medical Officer. Chapter partners are senior leaders who integrate medical compliance strategies across 90 markets, aligning with Roche Pharma's strategic goals. As the Lead, OneRoche Governance and Medical Compliance, you will act as a primary point of escalation, connecting global affiliates, functions, and product teams to the R&D Deputy Chief Medical Officer, focusing on strategic management, risk oversight, and regulatory compliance.

Your scope includes supporting councils and boards, managing operational quality reviews, developing the annual medical compliance risk registry, and ensuring robust governance on behalf of the Chief Medical Officer.

Your Opportunity:

• Owns the end-to-end medical compliance oversight strategy, guiding decisions and governance processes while driving solutions that do not require escalation to governance bodies.

• Manages the strategic portfolio of medical compliance risks and opportunities, working with Group Audit and Risk Advisory (GARA) to mitigate enterprise-level risks and escalate issues effectively.

• Facilitates the operation of governance bodies and prepares critical executive updates, including the annual Regulatory and Medical Compliance update for the Corporate Governance and Sustainability Committee (CGSC), alongside Pharma end-to-end Quality Reviews.

• Architects and coordinates the communication and implementation of governance-approved solutions, decisions, and regulations across Roche Pharma and Diagnostics, ensuring cohesive medical compliance oversight.

• Builds and maintains partnerships across global affiliates, Pharma and RED functions, Risk & Opportunity Management, and compliance-related teams to foster expertise and drive enhanced medical compliance outcomes.

• Oversees medical compliance activities related to GCP, GVP, MDR, IVDR, SaMD, and other regulations, ensuring effective methodologies and guardrails for a unified OneRoche approach.

• Assesses, triages, and escalates medical compliance cases (e.g., risks, issues, and queries) to governance bodies or the Medical Compliance Advisory Network of Experts as needed.

Who you are:

• Bachelor’s degree or equivalent in the scientific or quality-related field or equivalent combination of education, training, and experience.

• You bring over 10 years’ of experience in the pharmaceutical, biotech, or medical device industry, with expertise in the end-to-end development and commercialization of products and associated Medical Compliance regulations (GCP, GVP, MDR, IVD, and SaMD).

• Skilled in implementing and applying risk management methodologies, including ISO 31000, particularly in Regulatory and Medical Compliance contexts.

• Proven leadership experience in team management, mentoring, coaching, and collaboration within highly matrixed organizations and cross-functional environments.

• Strong expertise in navigating global regulatory requirements and ensuring compliance in delivering medical activities aligned with development and commercialization objectives.

• Demonstrated project management capabilities, leading multiple teams and executing project plans to achieve desired outcomes effectively.

Preferred:

• MBA or advanced degree

• Experience interacting with regulatory authorities or performing quality audits

• Expert-level use of data and information to drive insight and strategy.

• Experience hosting health authorities and successfully delivering quality outcomes.

• External perspective on trends within the pharma and diagnostics industry and insights into the established actions of peer organizations.

• Proven ability to assimilate new and emerging compliance information or trends and translate into implementable positions for Roche to operate compliantly and effectively.

Relocation Benefits are not available for this job posting.

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.