Director, R&D Quality Business Partners

Director, R&D Quality Business Partners United States – Remote, United States - California - Los Angeles Clinical Development & Clinical Operations RegularJob DescriptionAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices (GxP). You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice on GxP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality and Medical Governance groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead role in R&D vendor selection, on-boarding, relationship management and governance. You may lead special projects that advance the capabilities of multiple team members across R&D Quality Business Partners. You may be a standing member of the overall R&D Quality and Medical Governance Extended Leadership Team with responsibilities for helping build and shape capabilities, and short- and long-range infrastructure across the overall R&D Quality and Medical Governance organization.
EXAMPLE RESPONSIBILITIES: Serves as the Quality Business Partner lead for assigned Gilead R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on all internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings.Supports deviation identification, reporting, and CAPA development.Leads intra/inter-departmental teams that support operations (e.g., evaluation of new regulations and potential implications for Gilead R&D and/or R&D vendors).Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.Collaborates with other R&D Quality and Medical Governance teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.Provides matrix management and leadership to project teams.Provides accurate and thorough input and recommendations into resource plans required to complete team deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience PharmD/PhD with 8+ years' experience.MA/MS/MBA with 10+ years' relevant experience.BA/BS with 12+ years' relevant experience.Extensive experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.Proven track record of successfully managing large scale, complex, time-sensitive projects.Rest of World Education & Experience BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in quality, compliance or a related field.
Knowledge & Other Requirements Expert knowledge of the drug development process and GxP, including worldwide regulations and their application to cross-functional drug development.Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma industry, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC).Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.Strong interpersonal skills and understanding of team dynamics.Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.Strong negotiation and conflict resolution skills.Strong coaching capabilities to mentor/develop staff.When needed, ability to travel.
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