Senior Clinical Quality Compliance Lead, Genentech Research and Early Clinical Development
Employment Type: Full-Time
This position serves as the primary Quality and Compliance Office (QCO) point of contact for Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) compliance support for Genentech Early Clinical Development (ECD) therapeutic area and clinical study teams.The Principal Clinical Quality Compliance Lead serves as a conduit to the broader organization to ensure a culture of quality and compliance. The Principal Clinical Quality Compliance Lead will leverage his/her compliance expertise coupled with a comprehensive understanding of the Research and Development landscape to proactively contribute to the Genentech Early Clinical Development organization. The Principal Clinical Quality Compliance Lead 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, guidances and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies.Key Activities:* Provides expertise and strategic guidance for the conduct of Genentech Early Clinical Development study programs and establish measures that will enhance compliance and successful clinical trial conduct.* Utilizes a risk-based strategy to identify and escalate compliance issues to leadership; establish and execute an effective and comprehensive action plans to address quality and compliance risks.* Develops relationships with key internal business partners and stakeholders: Quality, Regulatory, Safety, Vendor Alliance Management, and other key functions to enable transparency, escalation, and resolution of quality and compliance matters.* Fosters 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 ECD stakeholders on GCP compliance related activities/issues and serve as a GCP expert/consultant for QCO colleagues.* Operate as a trusted partner and member of clinical study teams providing team leadership, oversight, guidance and subject matter expertise.* Develop strong relationships with ECD personnel across functions and teams providing coaching and compliance guidance* Collaborate with stakeholders in conducting ongoing risk assessments of clinical trial activity in order to identify: priority studies, compliance trends/metrics, and high-risk vendors.* Identify potential compliance matters and support the implementation of methods for improvement and resolution in a pragmatic and effective manner.* Identify trends in quality events and collaborate with department management and stakeholders to ensure risk-based solutions are implemented in a timely manner.* Collaborate with ECD stakeholders in the conduct of Quality Assessment Activities (QAA) at the investigational site or through internal desktop assessments. (Potential travel 10%)* Identify and escalate significant compliance issues to QCO and relevant leadership, including the assessment of serious breaches.* Contribute to the Quality to Quality relationship governance with CRO Quality Team member for the ongoing assessment, review, and mitigation of quality and compliance issues on gRED programs.* Support ECD clinical teams/functions by providing guidance during and in drafting responses and Corrective Action/Preventative Action Plans (CAPAs) to internal/ external audits, quality events, site non-compliances and external inspections (as required).* Support the ECD Quality Management System activities including self-reporting of deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation.* Provide support and guidance during and following internal audits and external regulatory inspections (as required).* Present GCP training to ECD functions based on identified needs.* Maintain high level expertise in US and international GCP guidances/regulations as well as internal Policies and Procedure that may impact drug development.* Lead or participate in quality and compliance initiatives, as assigned.* Performs any other tasks as requested by Management to support quality oversight activitiesThese 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* 10 - 13 Years with Masters experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization.* Expert knowledge of international GCP drug development guidances and regulations, including USA (FDA), EU (EMA, MHRA) and ICH.* Experience in managing clinical quality and GCP compliance issues and expert knowledge of the drug development processes.* Experience with cross-functional stakeholder management.* Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.* Ability to influence people at different levels and negotiate cross functionally in matrix organization to resolve conflicts.* Ability to influence and lead both with and without authority, excellent problem solving and decision-making skills.* Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance and escalations.* Background in compliance of computer systems and validation (21 CFR Part 11), desired, not required.* 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, and PowerPoint.