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Genentech Clinical Quality and GCP Compliance Lead in South San Francisco, California

Clinical Quality and GCP Compliance Lead

South San Francisco

California, United States of America

Job ID: 201905-115125

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The Position

Description:

This position serves as the primary Quality and Compliance Office (QCO) single point of contact for GCP/GVP compliance support for Genentech Early Clinical Development (ECO) therapeutic area and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies.·

As an expert, the Clinical Quality Compliance Lead (CQCL) will utilize a risk-based strategy to prioritize QCO support for clinical trial activities, identify and escalate compliance issues, enable pro-active decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition the CQCL will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters. .

This position serves as an important conduit to the broader organization to ensure a culture of quality and compliance. Incumbent will leverage his/her compliance expertise coupled with a comprehensive understanding of the R&D landscape to proactively contribute to the Genentech Early Clinical Development organization. Incumbent will communicate and interface with a host of internal cross-functional partners, both within Genentech and other Roche functions, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The CQCL will actively contribute to the.development and implementation of Policy/Standard Operating Process I Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within the Genentech Early Clinical Development organization.

The CQCL is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.

Responsibilities:

  • Provide quality leadership and direction to Genentech ECO stakeholders on GCP related activities/issues and act as GCP expert/consultant for QCO colleagues.

  • Act as QCO member of clinical study teams for relevant Therapeutic Areas.

  • Lead or participate in quality and compliance initiatives, as assigned.

These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job; however, they are instead intended to describe the general nature and level of the work. Different levels of responsibility and accountabilities may be assigned to take account of the skills and capabilities and experience of the individual.

Requirements:

  • Bachelor's degree in scientific, health sciences or quality related field.

  • Minimum of 12-15 years within a pharmaceutical drug development GCP-related discipline.

  • Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines.

  • Previous experience managing quality and GCP compliance issues.

  • Experience with cross-functional stakeholder management.

  • Expert knowledge of the drug development processes.

  • Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.

  • Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.

  • Ability to influence people at different levels and negotiate cross functionally in matrix organization to resolve conflicts.

  • Ability to build and sustain meaningful relationships with business stakeholders and partners.

  • Pro-active, solution oriented mindset and sound judgment for evaluation of risks, guidance and escalations.

  • Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning.

  • Highly self-motivated, well organized, confident, possessing a solution oriented mindset and able to develop innovative solutions to issues.

  • Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

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

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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