Description
**ABOUT AMGEN**
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.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
**ABOUT THE ROLE**
In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience.
In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers.
**Roles & Responsibilities:**
+ Perform tactical batch disposition activities in support of lot release.
+ Enter and approve analytical data in LIMS.
+ Review and approve batch record and production documentation.
+ Initiate Quality records for supplier related changes.
+ Collaborate with global complaints team to request supplier assessments and review and approve associated investigations.
+ Travel to regional suppliers and Contract Manufacturers in India to support person-in-plant activities, routine quality oversight, and audit activities.
+ Provide data to the global networks to support Quality Management Processes.
+ Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
+ Take part in operational and quality improvement initiatives, programs, and projects.
+ Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
+ This role may require working in shifts or extended hours within the same shift to support global time zones.
**Basic Qualifications and Experience:**
+ Master’s / Bachelor’s degree with 8 to 12 years of experience in quality management systems or a related field OR
+ Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR
+ Diploma with 8+ years of experience in quality management systems or a related field.
**Functional Skills:**
**Must-Have Skills:**
+ Working foundation in quality assurance roles.
+ Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
+ Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them.
**Good-to-Have Skills:**
+ Experience in investigations, project management and trending and analysis.
+ Relevant experience in Supplier Management and/or contract manufacturing oversight.
+ Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging).
+ Proven experience in designing and/or improving processes.
+ Desire to partner with internal and external stakeholders across teams.
+ Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
+ Experience with Microsoft Office Tools including Excel, Word, and PowerPoint, Power BI
**Soft Skills:**
+ Excellent analytical and troubleshooting skills.
+ Strong verbal and written communication skills
+ Ability to work effectively with global, virtual teams
+ High degree of initiative and self-motivation.
+ Ability to manage multiple priorities successfully.
+ Team-oriented, with a focus on achieving team goals
+ Strong presentation and public speaking skills.
**EQUAL OPPORTUNITY STATEMENT**
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.
We will ensure that individuals with disabilities are provided with 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 an accommodation.
