FAQs
What is the primary role of the Quality Compliance Senior Manager at Amgen?
The primary role is to provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in the clinical development program.
What are the key responsibilities of this role?
Key responsibilities include serving as a GCP Subject Matter Expert, conducting risk-based GCP audits, managing quality events and regulatory inspections, ensuring quality oversight for risk assessment, analyzing data quality trends, and coordinating key technologies for data collection.
What qualifications are required for this position?
Candidates should have experience in Quality Management or Quality Assurance in the pharmaceutical/biotech industry, expertise in Quality Management Systems (QMS), strong knowledge of Clinical R&D and global regulations, and experience within GCP, including audits and inspections.
Is leadership experience considered important for this role?
Yes, leadership or mentoring experience is considered a plus for this position.
Where is the position located?
The position offers the ability to work flexibly from home, with regular office work either from the Cambridge or Uxbridge next-generation workspace.
What kind of company culture does Amgen promote?
Amgen promotes a diverse and inclusive community where teammates are empowered to bring ideas to the table and act, valuing professional and personal growth and well-being.
What benefits does Amgen offer to employees?
Amgen offers a generous Total Rewards Plan that includes health, finance and wealth benefits, work/life balance, and career benefits along with vast opportunities for learning and movement within the global organization.
How does Amgen ensure equal opportunity in employment?
Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
What accommodations are available for individuals with disabilities during the hiring process?
Amgen ensures that individuals with disabilities are provided reasonable accommodations to participate in the job application or interview process and to perform essential job functions. They can request accommodations directly.