Senior Specialist QA (Remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Specialist QA
What you will do
Let’s do this! Let’s change the world!
Does the thought of building an entirely new digital quality management system, excite you? Do you love to design and streamline processes within a hard-working team? If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to be part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.
Be part of the Amgen Digital Quality Management System, a transformation that will encompass the process redesign, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations. When completed, the Digital Quality Management System will be a cornerstone for the Quality End-to-End Transformation delivering a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO).
In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead.
Specific responsibilities include but are not limited to:
Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across Amgen Operations and R&D, to the Digital QMS platform for health and control processes.
Leads Digital QMS audit & inspection readiness, deviations and change control activities
Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS
Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
Manages and provides oversight of documents / records within the Quality Management System
Oversight of process key performance indicators and metrics
Manages external contractors providing services to the Digital QMS
Working across teams managing priorities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Senior Specialist QA professional we seek is an individual contributor with these qualifications.
Doctorate degree & 2 years of quality / compliance experience
Master’s degree & 6 years of quality / compliance experience
Bachelor’s degree & 8 years of quality / compliance experience
Associate’s degree and 10 years of quality / compliance experience
High school diploma / GED and 12 years of quality / compliance experience
Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
Ability to converse technically with mechanical, electronic, software, and quality engineers
Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304)
Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
Proficient working on multiple projects in a deadline driven environment
Strong decision making and organization skills with the ability to prioritize multiple business priorities.
Experience in project management, process improvement and quality system management
Effective verbal and written communication skills (writing and presentations) in English.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $136,995 – $156,890.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.
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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