Principal Quality & Compliance Manager

Genentech in San Francisco, CA

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
This strategic leadership role 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 groups 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. In addition, incumbent serves as the core Quality & Compliance Office (QCO) representative for the Global Quality Management System (QMS) in Genentech Early Clinical Development. This is achieved by: Proactively identifying and managing changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies. Working collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and providing input on any unique business requirements utilizing strong interpersonal, influencing, and negotiating skills. Identifying and anticipating potential problems impacting the ability to meet business goals; developing and implementing methods of improvement and resolution in a pragmatic and effective manner. Maintaining awareness of international GCP and GVP regulatory requirements and industry best practice with the help of the PD partners in Quality, Safety and Regulatory to promote quality and compliance within the function by embedding quality principles throughout the organization. Responsibilities: 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. Acts as key strategic expert interfacing with internal and external stakeholders for early landscaping, planning and execution and delivery of the ECD Quality Management-related projects while proactively communicating status, issues, and proposed solutions to the ECD LT, functional leadership and QCO. Oversees maintenance of ECD QMS systems and activities, including the annual Quality Plan, ECD Quality Handbook, and management of non-study specific, ECD Corrective and Preventative Action Plans (CAPAs). Provide support and guidance for ECD QMS activities including self-reporting deviations, root cause analysis and CAPA plan evaluation. Ensure timely closure of ECD non-study related CAPAs, resolve conflicts to closure and align efforts with applicable Quality & Compliance organizations (including QCO staff), to ensure that systemic findings and/or trends are incorporated are mitigated. Lead the development and trending of metrics programs within QCO for quality-related activities, assessing functional areas for trends and recommend mitigating/remediating actions in collaboration with QCO Leadership to ensure that issues/risks/trends are appropriately escalated & communicated to business partners. Identifies and anticipates trends in quality issues and collaborates with QCO LT to insure risk­managed 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. 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 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 R8tD 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.

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