Description: The Principal Quality & Compliance Manager, Governance, Standards, and Continuous Improvement (GSCI), is a strategic leadership role within gRED Early Clinical Development’s Quality and Compliance Office (QCO). This position serves as an important conduit to the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable related processes and procedures. Given the nature of the group's work, incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.
The Principal Quality & Compliance Manager will set the strategy for his/her respective team and actively contribute to the development and implementation of continuous improvement initiatives, and Policy/Standard Operating Process / Procedures tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution for functions impacted within the Genentech Early Clinical Development organization.
Understands the Genentech and Roche organization, particularly ECD and Product Development organizational dynamics. Builds and manages key relationships within ECD and various global functions (Product Development, pRED, US Medical Affairs, etc.) to better understand and address the compliance-related needs of the business in order to better drive the strategic direction for compliance activities within ECD and to execute global medical and healthcare compliance activities.
Partners with other departments including, but not limited to: Drug Safety, Product Development Quality, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, and the Healthcare Compliance Office, etc. Connects with managers of equivalent level (or higher) and leverages those collaborations to support and collaborate with QCO and gRED Early Clinical Development.
Provides advice to the business with respect to the development of cross-functional SOPs, Policies or Work Instructions for ECD.
Participates on GVPC (a global cross-functional team) as the delegate to the Director, Head of Governance, Standards, and Continuous Improvement.
Provides team leadership (oversight, guidance and subject matter expertise) and responsible for the strategic direction of the team to meet organizational objectives.
Identifies, recruits, hires and manages a team of 2-3 direct reports.
Anticipates change, and manages resources to support the team for continued success and value.
Partners with other members of the QCO Leadership Team to optimize and continually improve department processes, maintain role definitions and standards, and develop role-based competency and training programs for staff.
Helps ensure consistent compliance with and communication of corporate and other governing policies, procedures, regulations, laws and other pertinent guidelines for core ECD activities.
Determines and drives the development of annual and longer-range team objectives, plans, programs, projects and budgets for related compliance efforts.
Builds prominence of ECD and the QCO at the global level through key programs and communications.
Collaborates with the Head of QCO’s Clinical Quality Compliance Team on the implementation and maintenance of the Functional Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the Global Roche GCP/GVP Quality Manual and QCO Quality Plan.
Identifies and anticipates trends in quality issues and collaborates with QCO LT to insure risk-managed solutions are implemented in a timely fashion.
Provides expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Leads and/or facilitates the process of continuous process improvement and leads internal and global cross- functional initiatives by overseeing analysis of “to be” processes; forms, templates and related process documents to ensure alignment, accuracy, and adherence to relevant internal/country/local legal and regulatory requirements.
Challenges and influences the modification/removal of inefficient processes, and maintains highest levels of awareness, expertise in international GxP regulatory requirements, and project-specific procedures applicable to the clinical trial methodology.
Provides regular updates to senior management functions and participates in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.
Leads or participates on quality and compliance initiatives, as assigned.
Performs any other tasks as requested by Management to support quality oversight activities.
Who You Are
Qualifications & Requirements:
Bachelors degree required (life science or other relevant healthcare discipline is preferred).
Minimum of 12 - 15 Years/10 - 13 Years with Masters experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization.
Previous experience in building and leading teams; coaching and developing others.
Previous experience in developing Systems/SOPs for an R&D Organization, experience in implementation of new processes, proven success facilitating change within a complex organization.
Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity, ranging from strategic to highly tactical in nature.
Must demonstrate knowledge of GCP/ICH and QA issues within a global pharmaceutical organization.
Advanced understanding of numerous clinical development functional areas. Must be able to work independently majority of the time, ability to prioritize, identify conflicts and meet deadlines.
Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning; strong interpersonal skills.
Proven ability to influence people at different levels in a matrix organization and assist integration across locations and functions.
Strong aptitude to apply advanced theoretical knowledge and contributes to the development of new principles and concepts to independently address unusually complex problems.
Exercises sound and independent judgment in methods, techniques and evaluation criteria for obtaining results.
Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.
Highly self-motivated, well organized, and able to develop alternative solutions to issues.
Excellent communication and presentation skills
Listening, interpreting and summarizing information
Clear and concise verbal communication
Professional and concise written communications –exceptional attention to detail required
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.