Specialist Quality Complaints Investigations Oversight

Job Summary

Amgen is seeking a 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 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 stakeholders across Amgen to enable issues resolution and continuous improvement.

Key Responsibilities:

• Applies knowledge and subject matter expertise to ensure end-to-end oversight of major complaint investigations with moderate to high impact (e.g., level 2 complaint investigations)
• 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
• Evaluates subject matter expert assessments
• Escalates potential Quality issues to Management

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality / Manufacturing / Product Development / Safety / Research experience

OR

Bachelor's degree and 5 years of Quality / Manufacturing / Product Development / Safety / Research experience

OR

Associate's degree and 10 years of Quality / Manufacturing / Product Development / Safety / Research experience

OR

High school diploma / GED and 12 years of Quality / Manufacturing / Product Development / Safety / Research experience

Preferred Qualifications

• 4+ years of quality and manufacturing and or Product Development/Safety/Research experience in biotech or pharmaceutical industry
• Advanced Degree in a Science Field

• Demonstrated skill in facilitating complex investigations from initiation to completion
• Knowledge of Root Cause Analysis (RCA) process
• 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.
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
• Ability to interact effectively 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

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.

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 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.