88-50102011 Chapter Lead, PDQ Quality Policy

The Position

Genentech, Inc. seeks a Chapter Lead, PDQ Quality Policy at its South San Francisco, CA location.

Duties: Directly engage with global health authorities (HA) through innovation forums, symposia, conferences, trade associations and other routes, in order to influence HA regulations and industry standards. Review draft regulatory guidelines and provide evidence-based recommendations to HAs on risk-proportionate approaches. Monitor regulatory trends and business intelligence relating to new products and pipeline strategies, and establish internal quality policies to ensure regulatory compliance for drug development and maintain our license to operate. Lead a multidisciplinary network of stakeholders that are contributing to quality policy objectives under an end-to-end quality policy strategy. Present at global conferences on regulatory and quality topics. Review quality data (including inspection information, audit information, and deviations) in the Veeva Vault Quality Management System. Telecommuting permitted 100% from within the U.S. 15% international and domestic travel, fully reimbursed.

Education and experience required: Bachelor’s degree, or foreign equivalent degree, in Biomedical Science or Biology or related field and 8 years of progressive, post-baccalaureate experience in scientific, policy, or quality-related position

Alternative education and experience required: Master’s degree in fields specified and 6 years of the specified experience

Special Requirements:

Position requires 3 years of experience with each of the following:

• Applying knowledge of how pharmaceutical legislation and guidelines are developed by health authorities 

• Applying knowledge of global regulatory frameworks for pharmaceuticals

• Applying knowledge of pharmaceutical regulation and guideline requirements 

• Pharmaceutical policy development

• Leading multidisciplinary stakeholder networks

Position requires 1 year of experience with the following:

• Veeva Vault Quality management system

The expected salary range for this position based on the primary location for this position of California is $246,605 to $307,700 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Worksite: 1 DNA Way, South San Francisco, CA 94080

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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