For Current Gilead Employees and Contractors:

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At 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

POSITION OVERVIEW:

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 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 key 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.

RESPONSIBILITIES:

• Design and implement the Quality Strategy for the China Development Programs.
• Represent Quality on China Global Development Teams.

• Lead Quality risk assessment for China clinical development and provide these insights to the R&D Quality Audit Management program in order to prioritize audit oversight activities and advise on modifications where necessary.
• Act as R&D Quality point of contact for China National Medical Products Administration (NMPA) and other Health Authority Inspections of Gilead China Affiliates and clinical investigator sites.
• Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Affairs, Regulatory Operations and Clinical Data Sciences, Patient Safety.
• Collaborate with R&D Quality Oncology, Virology and Inflammation Quality Leads aligning on cross Therapeutic Area risks and Quality Oversight strategy.
• Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.
• Support the analysis and interpretation of key quality data for the presentation and reporting to China, functional and executive leadership.
• Support the management of critical and/or complex quality events for clinical trial activity in China.
• Lead Quality activities to support product submissions and responses to Health Authorities.
• Provide expertise in in licensing and collaboration activities as applicable.
• Lead/oversee management of internal inspection readiness activities throughout program life cycle for Gilead China study teams.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Provide guidance and training on relevant China GxP regulations and guidelines to cross-functional business partners.
• Serve as an expert and provide guidance on and interpretation of global Gilead policies and procedures for internal stakeholders.
• Supports overall R&D Quality
• Develop and train, internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
• Lead/Support intra or interdepartmental teams such as continuous improvement initiatives.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Education & Experience

• MA/MS/MBA/PharmD/PhD with 8+ years’ experience.
• BA/BS with 12+ years’ relevant experience.
• Expert knowledge and experience with world and regional, particularly China, Regulatory and Drug Development regulations.
• Extensive experience leading cross-functional activities across a broad spectrum of Quality Management System (QMS) and Quality Risk Management (QRM) or related strategies, programs, projects and other activities.
• Extensive leadership experience and proven effectiveness, whether through direct people leadership or matrix leadership.
• 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.
• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Knowledge & Other Requirements

• Expert knowledge of the biopharma industry, as evidenced by proven track record in setting short- and long-range business strategies and plans.
• 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).
• Exceptional 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. Able to distill complex matters into a clear business case and roadmap for execution.
• Strong negotiation and conflict resolution skills.
• Strong coaching capabilities to mentor/develop staff.
• When needed, ability to travel.

职位概述： 您将作为指定团队的研发质量业务合作伙伴，例如吉利德研发职能或支持吉利德研发的供应商。您将为影响研发质量、风险管控和持续改进的跨职能的实践（GxP）提供战略性、专业的建议和咨询，。您将指导指定团队关于吉利德质量政策和程序标准、GxP法规及其他要求。您将提供关于GxP风险最小化和缓解的专业建议。您将帮助吉利德中国研发及其合作伙伴理解风险的潜在影响及最佳应对风险的替代方案。您还将在提升质量风险或问题时提供指引和支持。您将参与和/或领导质量论坛、跨职能团队和/或项目。您将作为指定团队与质量管理体系（QMS）相关通信的中心联系人；整合并传递及时信息和资源以协助指定团队。您将与其他研发质量小组合作，确保及时支持和资源给指定团队，包括数据、报告、培训、稽查、检查、风险评估和偏差/CAPA管理支持。您可能代表吉利德参与药监当局的检查。在适用的情况下，您将在研发供应商的选择、合作初期、关系管理和治理中发挥关键作用。您还可能领导特殊的项目，来推进全球研发质量其它团队的成员的能力。

职责：

• 设计并实施中国发展计划的质量战略。
• 在中国全球发展团队中代表质量团队。
• 领导中国临床发展的质量风险评估，制定基于风险的稽查为先为重的研发质量稽查管理计划，并就必要时的修改提供建议。
• 作为中国国家药品监督管理局（NMPA）及其他卫生当局检查吉利德中国子公司和临床研究（包括在临床研究者、研究中心的检查）的研发质量联系人。
• 与关键业务利益相关者建立强有力的伙伴关系，包括临床发展、临床运营、注册事务、注册运营和临床数据科学、患者安全。
• 与研发质量部不同治疗领域 （肿瘤学、病毒学和炎症）的管理层合作，协调跨治疗领域风险和质量监督策略。
• 提供基于风险的理由以促进决策制定，展示良好的判断力，并支持制定和执行有效和全面行动计划以化解质量和合规风险。
• 支持关键质量数据的分析和解读，支持对吉利德中国以及职能部门的最高领导层的报告。
• 支持中国临床试验活动中关键和/或复杂质量事件的管理。
• 领导质量保证的相关活动以支持产品的递交和对药监当局的回复。
• 在适用的情况下，在in licensing和与外部机构的合作中提供专业知识。
• 领导/监督吉利德中国研究团队在项目生命周期内进行有效迎接/准备药监当局检查的活动。
• 通过评估内部稽查、药监当局的检查和质量事件的结果以及识别内部偏差的趋势，识别并推动需要持续改善的流程改进。
• 向跨职能业务合作伙伴提供有关中国GxP法规和指南的指导和培训。
• 作为专家，为内部利益相关者提供全球吉利德政策和程序的指导和解释。
• 支持整体研发质量。
• 根据需要开发和培训内部员工。这包括培养个人对质量的承诺和组织内的质量文化。
• 领导/支持部门内外的团队，如持续改进倡议。
• 确保自己的工作符合既定实践、政策和流程，以及任何监管或其他要求。

教育与经验：

• 如持有硕士/硕士/MBA/药学博士/博士，期望具有8年以上相关经验。
• 如持有学士学位，期望具有12年以上相关经验。
• 具有全球，特别是中国，新药开发监管法规的专业知识和经验。
• 在质量管理系统（QMS）和质量风险管理（QRM）或相关策略、计划、项目和其他活动中，具有广泛的跨职能活动领导经验。
• 具有广泛的领导经验和证明经过的有效性，无论是通过直接人员领导还是矩阵领导。
• 优先考虑具有全面质量管理方法论的工作经验，如Lean Six Sigma,。
• 有成功管理大规模、复杂、时间敏感项目的可靠记录。
• 在内部和外部培养和维护战略关系和合作的强有力记录。

知识与其他要求：

• 通过在设定短期和长期业务战略和计划方面的可靠记录，证明对生物制药行业的专业知识。
• 具备药品开发过程和GxP的专业知识，包括全球法规及其在跨职能药品开发中的应用。
• 具备从早期研究到上市后各个阶段的药品开发中涉及的所有关键职能的专业知识。
• 充分了解标准、系统、政策和程序，这些知识使生物制药行业能够实现QMS运营和合规，包括良好实验室规范（GLP）、良好临床实践（GCP）、良好临床实验室规范（GCLP）、良好药物警戒（GVP）和电子系统合规（ESC）。
• 出色的人际交往能力和对团队动态的理解。
• 卓越的沟通和组织能力。能够向不同组织层面，包括领导团队、高管和指导委员会，有效传达项目方向和状态。能够将复杂问题简化为清晰的商业案例和执行路线图。
• 优秀的谈判和冲突解决技能。
• 卓越的指导能力，以指导/发展员工。
• 如有需要，能够接受出差。

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.