/ Hiring

Head of Biologics External Quality

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Purpose:

Accountable for the deployment andrealization of the Quality and Compliance strategy for PharmaGlobal Technical Operations (PT) External Quality Operations CMO - Biologics.

Key Responsibilities:

• Directaccountability for Quality and Complianceactivities and organization across PT’s external CMOsfor Biologics
• Leadingdeployment and full realization of the PT QualitySystem requirements through Quality Agreements and Contract  Quality Requirements  with externalCMOs.
• Ensurean objective, proactive cGMPcompliance program is established andoperational.
• Qualityresponsibility for extention ofmanufacturing network into EM (India, Russia, Brazil) and forDevices
• Product qualitymanagement activities
• End-to-end externalCMO - wide Quality Risk management
• Directcontinuous improvement activities ofexternal CMOs toimprove Quality and Compliance performance.
• Sponsor forthe Global Quality external CMO issues management process and system.
• Directlyresponsible for External Quality Operations CMO organization
• Overall budgetand financial performance for External Quality Operations CMO organization.
• Accountablefor demonstrating and realizing Roche’score values and expected behaviors.

Who You Are

• Experiencein multiple technical Drug Productplatforms (bulk drug substance,steriles, devices andcombination drug products)and product life cycle
• 5 to10 years operational experience as PT site head/QSH
• Experiencewith working in matrix organizations
• SolidQuality Business Acumen
• Atleast 15 years industry experience in pharma/biopharma business
• Strongcommunication, collaboration skills
• Strong interpersonal skills  with provenhigh level influencing  and negotiationskills
• Excellent verbal and writtencommunication skills
• Excellent at building and maintainingconstructive and effective relations ships with internal and externalstakeholders
• Strong collaboration and team buildingskills across cultures, countries, technical competences, and organizationallevels.
• Capability to manage complex situations
• Ability to deal with concepts, ambiguityand complexity skillfully and comfortably
• Manages 3 to 5 direct reports. Total reporting in Bio: 80
• Ability tolead cross-site and network wide activities without direct line responsibility
• Strong quality and complianceunderstanding
• Strategic agility

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.