GCP审计员 - 全球研发审计
GCP Auditor - Global R&D Audit
### **职业类别**
质量
### **职位描述**
加入安进的患者服务使命
在安进，如果你觉得自己是更大事业的一部分，那是因为你确实是。我们共同的使命——为患有严重疾病的患者服务——推动着我们所做的每一件事。
自1980年以来，我们在对抗世界上最难治愈的疾病方面，帮助开创了生物技术领域。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年惠及数百万患者。安进正在推进广泛的药物管线，用于治疗癌症、心脏病、炎症性疾病、罕见病和与肥胖相关的疾病。作为安进团队的一员，你将帮助对患者的生活产生持久的影响，我们通过研究、制造和交付创新药物，帮助人们延长寿命，过上更充实、更幸福的生活。
我们获奖的文化是协作、创新且以科学为基础的。如果你热衷于挑战以及其中蕴含的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生命，同时改变你的职业生涯。
**GCP审计员 - 全球研发审计**
**你将负责的工作**
让我们一起行动，改变世界。你将加入安进研发质量审计团队，该团队由专家、专业且经验丰富的人员组成，具有全球范围内的职责，覆盖安进产品组合的所有开发阶段及上市后阶段。研发质量审计团队是安进研发质量组的一部分。
在这个研发质量的重要角色中，你将计划并参与安进临床试验活动的全球审计。你可能还会支持对临床现场和安进设施的监管检查。主要职责包括：
- 计划、执行并报告国际范围内的常规和直接的GCP合规性审计
- 作为复杂GCP审计的主审员
- 向研发质量管理层识别并传达合规风险
- 主持或参与监管机构的检查
- 参与或领导研发质量流程改进项目
- 撰写并参与研发质量跨职能受控文件的开发
该职位可能需要最多40%的国际出差
**我们对你的期望**
我们每个人都不相同，但我们都用自己独特的贡献来服务患者。作为一名有经验的专业人士，我们希望你具备以下资格和技能：
**基本资格**
查看英文原文
### **Career Category**
Quality
### **Job Description**
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**GCP Auditor - Global R&D Audit**
**What you will do**
Let’s do this. Let’s change the world. You would be joining Amgen’s R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.
In this vital role within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:
- Plan, conduct and report routine and direct GCP compliance audits internationally.
- Serve as a lead auditor for complex GCP audits
- Identify and communicate compliance risks to R&D Quality management
- Host and/or play a role in regulatory authority inspections
- Contribute to or lead R&D Quality process improvement initiatives
- Author and contribute to the development of R&D Quality cross functional controlled documents
The role can entail up to 40% travel to international destinations
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
**Basic Qualifications:**
- Doctorate degree OR
- Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
- Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
- Associate’s degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
- High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience
**Preferred Qualifications:**
- Postgraduate qualification
- Participation in process improvement initiatives.
- Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
- Experience of data mining, manipulation and data analytics would be advantageous
- Excellent written and verbal communication skills
**What you can expect from us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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**Salary Range**
104,725.10USD -141,686.90 USD