FAQs
What is the role of the Senior Manager Quality Compliance?
The Senior Manager Quality Compliance is responsible for strengthening and advancing Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies, particularly in deviation and audit management, while providing system and process support for SMQ staff.
What qualifications are needed for this position?
Candidates should have experience in Quality Management, Quality Compliance or relevant risk-based quality practices in the pharmaceutical/biotech industry, thorough knowledge of R&D processes and operations, and knowledge of international Good Pharmacovigilance Practice (GPvP).
What type of experience is preferred for this role?
Previous experience supporting regulatory authority inspections of pre-clinical, clinical research, and/or pharmacovigilance activities, along with leadership or mentoring experience, is preferred.
Is there a training component included in this role?
Yes, the role includes identifying skill gaps in the SMQ team and creating training programs, as well as providing training to Deviation Owners to enhance deviation record quality and management.
Where will the position be located?
The position allows for flexible remote work, with regular office work at either the Cambridge or Uxbridge workspace.
Does this role involve collaboration with other teams?
Yes, the Senior Manager Quality Compliance will collaborate with the R&D Quality Director to implement process improvements and support team activities including inspections and audits.
What opportunities for growth does Amgen provide?
Amgen offers vast opportunities to learn and move up and across the global organization, fostering professional and personal growth and well-being.
Are there any specific team responsibilities this role encompasses?
Yes, the role encompasses decision-making authority for Observation Research, Patient Support Programs, Market Research, and Social Digital Media, while collaborating with a colleague who handles decision rights for Pharmacovigilance and other areas.
How does Amgen support its employees' well-being?
Amgen has a generous Total Rewards Plan that includes health, finance and wealth benefits, work/life balance, and career benefits to care for teammates’ professional and personal growth.
Is Amgen an equal opportunity employer?
Yes, Amgen is an Equal Opportunity employer and considers candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.