Sr. Specialist Quality Complaints Investigations Oversight
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.Live
What you will do
Lets do this! Lets change the world!Job summary
Amgen is seeking a Sr. Specialist Quality Complaints Investigations Oversight, reporting directly to the Sr. Manager Quality Complaints Investigations Oversight 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 serves as lead investigator responsible for end to end management of complaints investigations for Amgen products on the market. Drives compliance and ensures consistency of major complaint investigations. Works with key partners across Amgen to enable issues resolution and continuous improvement.
This position will be located in Cambridge, MA.Key Responsibilities:
Applies in-depth knowledge and subject matter expertise to ensure end-to-end oversight of major complaint investigations with high impact (e.g., level 2 and 3 complaint investigations, quality defect investigations, trend and consolidated investigations)
Leads and participates on cross-functional teams in high quality Root Cause Analysis (RCA) and the necessary steps to mitigate issues
Develops responses to major investigations and determines appropriate corrective and preventive actions (CAPA)
Represents Quality on Deviation Review Team (DRT)
Ensures that the investigations reach an appropriate root cause conclusion and that mistake-proof CAPAs are identified and initiated
Manages deviations related to a Known Quality Defect, ensuring related complaints are investigated and documented per procedures
Ensures quality of complaint records
Applies analytical skills to evaluate complex situations using multiple sources of information
Drives execution regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Provides mentoring regarding complex issues to more junior staff
Evaluates subject matter professional assessments
Raises potential Quality issues to Management
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute 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
Advanced Degree in a Science Field
Demonstrated skill in facilitating complex investigations from initiation to completion
Expertise in Root Cause Analysis (RCA) process and ability to transfer that knowledge to other staff
Expertise in development management and complex investigations
Combination products expertise
Demonstrated ability to deep dive into technical issues and also appropriately manage upward
Ability to successfully manage workload to timelines
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong organizational skills, including ability to follow assignments through to completion
Enhanced skills in leading, influencing, and negotiating.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
Demonstrated ability to interact with regulatory agencies
Strong word processing, presentation, database and spreadsheet application skills
Excellent communication and executive presence (both written and oral), facilitation and presentation skills
Strong skill in working independently and to effectively interact with various levels
Skilled in risk management
Project management skills
Ability to travel +/- 20% 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, so we 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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.Amgen requires all staff in the United States and Puerto Rico 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.