高级经理 企业质量合规
Senior Manager Corporate Quality Compliance
### **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。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、制造和提供创新药物，帮助人们延长寿命，过上更健康、更幸福的生活。
我们获奖的文化是协作、创新和以科学为基础的。如果你对挑战充满热情，并且能抓住其中的机会，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。
**全球质量合规，高级经理**
**你将负责**
让我们一起行动，改变世界。
负责执行必要的全球质量合规任务和/或项目，以实现公司和部门的目标，包括以下活动：
- 协调并领导或参与全球质量合规审计，包括公司质量管理系统、安进各设施、合同设施、关联公司、关键服务供应商、供应商、合作伙伴和批发商，以评估符合所有适用法规的情况，并识别主要合规风险。
- 确保根据特定角色完成、维护和持续进行培训，以支持审计流程（例如，阅读并理解如何应用监管要求，包括法规、指南和标准的变化、趋势和期望等）。
- 支持制定年度审计计划，按指派任务进行
- 评估符合适当法规的状况，并参与评估纠正不足的行动计划。
- 提供技术和组织方面的领导，以解决现场和多现场的合规问题。
- 向高管管理层通报重大质量和合规风险。
- 在适用的情况下，作为全球受监管要求和检查承诺的专家。
- 在必要时为国内外监管机构的检查提供支持。
- 担任高级职位
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. 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.
**Global Quality Compliance, Senior Manager**
**What you will do**
Let’s do this. Let’s change the world.
Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:
- Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
- Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
- Supports preparation of the annual audit plans, as assigned
- Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
- Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
- Alertsexecutivemanagementofsignificantquality,andcompliancerisks.
- Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
- Provides support for domestic and international Regulatory Authority Inspections whennecessary.
- Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
- Interactswithotherfunctional area leadstoensurethatAmgenStandards, strategies,anddirectionare alignedwithexistingregulationsandregulatoryexpectations.
- Provides support for audit and inspection metrics, as necessary.
- SupportsContinualImprovementinitiatives,programs,andprojects.
- Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).
**Additional Requirements:**
- Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
- Certified Quality Auditor (CQA) or equivalent
- Travel: Domestic and International Approximately 50%
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
**Basic Qualifications:**
- Doctorate degree and 2 years of auditor experience OR
- Master’s degree and 6 years of auditor experience OR
- Bachelor’s degree and 8 years of auditor experience OR
- Associate’s degree and 10 years of auditor experience OR
- High school diploma / GED and 12 years of auditor experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
**Preferred Qualifications:**
- Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
- 50 % international travel requirement
- Knowledge of international regulations and standards
- Auditing certification preferred
- Detail oriented
- Organizational and multi task skills
**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, including remote and hybrid work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**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.
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**
138,264.40USD -187,063.60 USD