Amgen is seeking a Sr. Specialist Quality Complaints Product Team Member as part of the broader Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes 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 determines regulatory escalation for critical complaint failures and any action which may be necessary to show due diligence with trends in root cause. Drives connectivity between R&D, Safety, and Operations. Aligns with Product Quality Teams regarding annual product review requirements to ensure cohesive execution of required actions. Serves as final product subject matter expert (SME) for issues related to information reported from the field. Participates in aligned Product Development Team (PDT) meetings as product complaint subject matter expert.
+ Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance Amgen’s products
+ Leads and participates on cross-functional product teams in analysis of the situation and the necessary steps to mitigate issues
+ Authors Annual Product Review (APR) / Post Market Surveillance (PMS) complaint sections
+ Interprets SOP and regulatory requirements
+ Sets project timelines and priorities
+ Integrates complaints data and information into plans, deliverables and clear GMP documentation
+ Leads the partnership with Amgen Safety and Final Product Technologies
+ Communicates potential Quality and Safety issues to Sites / Stakeholders
+ Manages Safety Quality Investigations (SQI) and ensures proper connectivity with R&D Safety
+ Subject matter expert for final products and ensures quality of complaint records
+ Applies analytical skills and final product knowledge to evaluate complex situations using multiple sources of information
+ Focuses on ways to predict and prevent, leveraging leading indicators and data insights to proactively identify opportunities and challenges
+ Drives execution of regulatory and SOP requirements
+ Communicates complaint issues / data to sites / stakeholders
+ Active participant in the Safety Analysis Team (SAT) meeting as the Quality representative
Doctorate degree and 2 years of Quality experience
Master’s degree and 6 years of Quality experience
Bachelor’s degree and 8 years of Quality experience
+ 8+ years of quality and manufacturing experience in biotech or pharmaceutical industry
+ Bachelor’s 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 QMS
+ Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
+ Ability to travel +/- 10% of time to domestic and international Amgen sites
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
**_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._**
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 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.