Manager, Quality

For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech manufactures and commercializes multiple biotechnology products that have helped patients suffering from serious diseases and conditions, including breast cancer, colorectal cancer, non-Hodgkin's lymphoma, lung cancer, rheumatoid arthritis, cystic fibrosis and allergic asthma. The company is the leading provider of anti-tumor therapeutics in the United States.

Our continued growth has created an opportunity for a Quality Manager in our Oceanside facility. Please take this opportunity to learn about Genentech, where the creativity and openness of an academic environment meet the rigorous dedication of industry-leading professionals focused on improving and extending people?s lives.

Responsibilities:
The candidate will be responsible for developing, implementing and overseeing the daily operations of a Quality Control Microbiology group and ensuring that the laboratory is maintained in a state of GMP compliance, that all documentation is generated in accordance with GMP and that all reported results are accurate. He/she will plan, initiate, implement and oversee department activities with a focus upon ensuring attainment of department objectives. The Manager will provide performance management and career development for subordinate supervisory and/or technical staff, as well as develop and implement operational, policy and procedural directives for area(s) of assigned responsibility. He/she will review and approve recommendations and/or analytical QC data presented by subordinate(s) as appropriate and coordinate with other departments and conduct investigations as an area expert for appropriate discrepancies. The candidate will participate with senior and executive management in the decision making process for capital equipment expenditures and the acquisition of new technologies. The Manager will investigate, develop and implement new and creative ways to accomplish department goals in the most cost effective and productive manner while maintaining high quality standards. He/she will act as project leader to coordinate activities between divisions and provide scientific leadership. The candidate will represent the department during FDA and/or Regulatory Inspections, as well as interact with FDA inspectors and other regulatory agencies to present and defend QC data.

Requirements:
A Bachelor?s degree in Biology, Microbiology, Biochemistry or other relevant Life Science discipline and eight years of experience in a pharmaceutical/biotechnology lab is required. The candidate must have experience in supervising technical personnel and knowledge of industrial microbiology. Sterility testing experience is a plus. He/she will demonstrate excellent project management skills including the ability to plan, prioritize and complete own work and the work of others. Excellent interpersonal skills including the ability to effectively collaborate with staff from other departments is essential. The candidate must have excellent written and verbal communication skills and the ability to invest time to complete assignments as required. This may include working non-standard hours such as evenings and weekends as necessary. He/she will demonstrate strong spreadsheet, word processing and database skills necessary to process and present
technical data in a clear and concise manner.

Genentech offers one of the most comprehensive benefits packages in the industry. Join a company that attracts, retains and rewards talented and committed employees. Our culture emphasizes working hard, collaborating and sharing rewards. For immediate consideration, please visit www.gene.com/careers and reference Req. #1000013855. Genentech is an equal opportunity employer.