Manager Quality Compliance - Audit & Inspection Management

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this! Lets change the world!

As a member of the R&D Quality Compliance, Learning and Performance (QCL&P) organization, this Manager Quality Compliance of Audit & Inspection Management plays a key role in ensuring Quality and Compliance by driving and ensuring efficient and effective conduct of audits and regulatory inspections. This position will be reporting directly to the Business Process Owner of R&D Audit & Inspection Management within Quality Operations.

Job Responsibilities:

• Developing and implementing a cross functional inspection management infrastructure from preparation/planning through execution and performing key leadership roles within the inspection management team

• Developing and maintaining a comprehensive inspection readiness program, sustainable for increasing inspections from Research & Development across GxP and a wide range of regulatory authorities

• Integrating cross-functional stakeholder organizations into the inspection readiness

• Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels of management review

• Administratively and logistically facilitate and manage inspections and R&D partner audits hosted by R&D Compliance

• Own inspection management tools including inspection readiness SharePoint site(s); Smartsheet as well as MS Teams and manage logistics for inspection preparation/management

• Maintain inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Inspection Training

• Help administratively facilitate inspection management response process

• Ensure timely data entry as relates to audit / inspection conduct into Inspection Management System (IMS) and R&D CAPA System (RDCS)

• Responsible for GxP Intelligence and Regulatory Commenting as relates to audit / inspection Management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

• Doctorate degree

• Masters degree and 3 years of Quality / Compliance experience

• Bachelors degree and 5 years of Quality / Compliance experience

• Associate degree and 10 years of Quality / Compliance experience

• High school diploma / GED and 12 years of Quality / Compliance experience

Preferred Qualifications:

• 3 or more years in biopharmaceutical industry that includes GxP audit / inspection management, inspection readiness activities

• Experience hosting or participating in audits and / or regulatory inspections

• Knowledge of GLP, GCP and GVP global regulations as they relate to Clinical Development, Drug Safety and Drug Development

• Understanding of being risk based focused and prioritizing work based on Risk Management methodologies

• Detail-oriented with experience in Quality / Compliance functions

• Advanced computer skills, including knowledge of working with SharePoint Online, MS Teams, Smartsheet and Tableau

• Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization

• Work in a team matrix environment and independently interact with various levels of management

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com
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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.