Global Operations Quality Manager

Role Overview

• Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations
• This position leads collaborations at country and regional level, as assigned
• This position leads consultation on continuous improvement of established processes and procedures
• This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness
• This position may sit across the entire global portfolio or a particular asset(s)
• These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed
• With QA leading, this position supports study teams during regulatory inspections
• Develop and maintain guidance and process to facilitate DOQ support of Study Teams
• Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
• Provide training or awareness for new or established processes or guidance provided by DOQ
• Collaborate in developing and presenting DOQ content for distribution within the organization
• Author relevant content for the DOQ SharePoint site
• Act as lead on specified DOQ workstreams or assigned DOQ initiatives
• In collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQ
• Consult, develop, or identify opportunities for continuous improvement projects
• Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations
• Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
• Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
• Develop matrix relationships to involve process experts and conduct improvement activities
• Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization
• Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do

Requirements

• Working knowledge of Quality Management methods, systems, and relevant procedures
• Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials
• Experience in managing complex and sensitive operational challenges
• Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements
• Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders
• Experience in developing or contributing to processes and/or SOPs and/or WIs
• Ability to lead and execute continuous improvement
• Experience in inspection preparation, participation, and follow-up
• Experience with audits and inspections of sponsor/CRO/site/vendor
• Exposure to all phases of clinical trials
• Broad knowledge of Clinical Operations with prior regulatory knowledge desired
• Demonstrated leadership, critical thinking skills, and ability to influence teams driving them to shared consensus
• Strong verbal and written communication skills with ability to effectively communicate with a broad range of stakeholders at all levels to build strong, positive relationships under challenging and evolving landscapes
• Ability to interact with key stakeholders and create and present complex information effectively to promote excellence in quality
• Acute attention to details with ability to extrapolate facts and communicate succinctly and confidentially
• Strong cooperative team player with the ability to be flexible and adapt to a changing environment
• Used to working in a multidisciplinary setting with a strong customer-orientation
• Ability to effectively manage multiple priorities simultaneously
• Good planning, prioritization, and organizational skills, and able to work independently or within a group

Tech Stack

• Google Cloud Platform

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time