高级质量经理
QA Sr Mgr
### **职业类别**
质量
### **职位描述**
### 加入安进为患者服务的使命
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的世界。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、罕见病以及肥胖及其相关疾病。作为安进团队的一员，你将帮助对患者的生活产生持久影响，我们研究、制造并提供创新药物，帮助人们延长寿命，过上更幸福的生活。
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，并能从其中的机会中找到动力，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。
**质量高级经理**
**你将负责**
让我们一起行动，改变世界。在这个关键角色中，你将利用你的专业知识，领导并建立合作伙伴关系，推动生物技术和生物制药科学的发展，从而扭转严重、中断生命的疾病局势。
- 项目管理指定的关键外部机械设备供应商的整改工作。
- 领导一支质量专业人员团队，监督外部机械设备供应商。
- 确保全球运营符合科学、监管和质量标准。
- 与外部供应链、工艺开发和组合产品质量管理团队跨职能合作。
- 推动变革，确保产品质量，创造多元化和包容的环境。
**主要职责**
供应商监督：
监控外部设备供应商的质量体系和绩效。
定义并执行质量要求。
管理供应商质量KPI和风险升级。
**团队领导：**
管理和发展指定的团队成员
与安进内部跨职能团队协作
**战术执行：**
领导有影响力的跨职能项目。
培养持续改进和卓越运营的文化。
**我们期待你做到**
我们每个人都不相同，但我们都…
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 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.
**QA Senior Manager**
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
- Program manage remediation of assigned critical external mechanical device suppliers.
- Lead a team of quality professionals overseeing external mechanical device suppliers.
- Ensure compliance with scientific, regulatory, and quality standards across global operations.
- Collaborate cross-functionally with teams in External Supply, Process Development, and Combination Product Quality.
- Drive change, ensure product quality, and create a diverse and inclusive environment.
**Key Responsibilities**
Supplier Oversight:
Monitor quality systems and performance of external device suppliers.
Define and enforce quality requirements.
Manage supplier quality KPIs and risk escalations.
**Team Leadership**:
Manage and develop assigned team members
Work collaboratively with cross functional teams across Amgen
**Tactical Execution:**
Lead impactful cross-functional initiatives.
Foster a culture of continuous improvement and operational excellence.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
**Basic Qualifications:**
Doctorate degree and 2 years of experience
OR
Master’s degree and 4 years of experience
OR
Bachelor’s degree and 6 years of experience
OR
Associate’s degree and 10 years of experience
OR
High school diploma / GED and 12 years of experience
**Preferred Qualifications:**
- Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics.
- 10+ years in Medical Device/pharma/biotech sectors.
- Extensive knowledge of:
- Quality systems (batch release, complaints, risk management).
- Global supplier management and device regulations.
- Strong leadership, communication, and problem-solving skills.
- Experience managing global teams, including during change.
- Travel up to 25%, domestic and international.
**What you can expect of 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.
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**Salary Range**
132,037.30USD -178,638.70 USD