Sr Technical Manager, Assessment
Genentech - San Francisco, CA

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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

POSITION SUMMARY:
Initiates and evaluates Genentech product complaint investigations (including technical, counterfeit, tampering, medical and clinical cases) in accordance with Standard Operating Procedures (SOP) to assist in protecting the efficacy and safety or Genentech marketed products and to ensure compliance with Food and Drug Administration (FDA) requirements, current Good Manufacturing Practices (cGMP), all applicable global health agency requirements, and Genentech policies and procedures.

Applies working knowledge of Genentech product, quality control and quality assurance policies and procedures to interact with customers to gather information; to initiate investigations in relevant Genentech business areas; and to confirm corrective actions are taken.

Provides information/documentation for Technical Meeting and Action Committee reviews of product complaints that include potential reporting to regulatory authorities and / or product recalls, and writes interim / final product complaint evaluation reports.

JOB RESPONSIBILITIES:
Lead product complaint investigations and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Identify and ensure product complaint investigation reports are reviewed and approved by appropriate levels of Management. Review and approve product complaint investigation reports and supporting documentation. Lead collaboration with departments to establish appropriate, efficient, and timely product complaint investigation strategies. Ensure appropriate application and integration of cGMP's into the product complaints management system. Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes. Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes.

Who you are

JOB REQUIREMENTS:
B.A. or B.S. degree (preferably in Life Science) and at least five years experience in relevant field(s), e.g., pharmaceutical manufacturing, quality management, pharmacy, nursing Sound knowledge of handling product complaints associated with small molecule products

Investigational skills to support complex and critical product complaints investigations. Sound knowledge of cGMP's or equivalent regulations. Ability to interpret and relate Quality standards for implementation and review. Ability to make sound decisions about scheduling, allocation of resources, and managing priorities. Ability to communicate clearly and professionally both in writing and verbally. Flexibility in problem solving, providing direction and work hours to meet business objectives. Demonstrated ability to understand and organize technical data for communication and analysis

Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply.

Genentech - 2 years ago - save job - block
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