Sr Specialist Quality Complaints
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Sr Specialist Quality ComplaintsLive
What you will do
Lets do this! Lets change the world!Job Description
Amgen is seeking a Sr. Specialist Quality Complaints Training and IS Systems as part of the broader Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and completes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.
The Sr. Specialist establishes and leads robust onboarding curriculum and training programs for members of the Product Complaints and Surveillance team. Leads development and maintenance of complaint staff training curriculum and content. Determines regulatory requirements for complaints curriculum and any action which may be necessary to ensure compliance with internal and external requirements.
Determines regulatory requirements (e.g. Data Integrity) for complaint IS systems and any action which may be necessary to show due diligence with Complaints IS systems. Establishes and performs data monitoring for complaint IS systems.Key Responsibilities:
Leads cross-functional teams to analyze, outline, and implement the strategy for complaint staff onboarding and ongoing training requirements
Demonstrates in-depth knowledge of complaint processes, systems, and requirements along with subject matter expertise to inform the right content and standard methodologies
Works closely with Operations Learning and Performance to develop strategy, content, and delivery mechanism to ensure alignment with corporate and regulatory requirements
Manages and drives continuous improvement for complaint staff training curriculum, onboarding, and related content
Drives Operational Excellence and champions change
Directs interactions with health and regulatory authorities during inspections, speaking on behalf of Amgen
Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the complaints IS systems
Leads cross-functional teams in analysis of complaint IS system issues and the necessary steps to address both immediate and future anticipated issues
Interprets IS regulatory requirements, performs informed gap assessments for complaints IS systems, and translates into SOP requirements
Focuses on ways to predict and prevent, using leading indicators and data insights to proactively find opportunities and challenges
Sets project timelines and priorities
Partners with key collaborators to include Medical Communication, Amgen Global Safety with shared IS systems, ensuring quality requirements are met
Responsible for Business Continuity Plans for Complaints IS Systems
Assists GPO to manage Process Standard, Process Overview and Multisite SOP to ensure alignment with document hierarchy and document templates.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.Basic Qualifications
Doctorate degree and 2 years of Quality experience
Masters degree and 6 years of Quality experience
Bachelors degree and 8 years of Quality experience
Associates degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experiencePreferred Qualifications
8+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelors Degree in a Science Field
Leadership skills and the ability to oversee multiple projects simultaneously
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Experience in driving decision making by using decision making principles
Understanding of industry requirements/expectations of a Quality Management System (QMS) Training Program
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Understanding of IS Systems related to management of quality processes
Ability to travel +/- 10% of time to domestic and international Amgen sites
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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
Join UsIf 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 cancer, 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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.