Senior Manager Quality Compliance

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

SENIOR MANAGER QUALITY COMPLIANCE - GOOD PHARMACOVIGILANCE PRACTICES (GPvP)

LIVE

What you will do

In this vital role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies in deviation and audit management. Additionally, you will provide system and process support for SMQ staff.

• Manage SMQ onboarding and maintain the onboarding guide
• Identify skill gaps in the SMQ team and create training programs, collaborating with Training & Development
• Conduct annual SMQ AV reviews, updates, and monitor monthly LMS completion reports
• Mentor SMQ team members in deviation management (system, process, and skills)
• Provide training to Deviation Owners to enhance deviation record quality and management
• Collaborate with the R&D Quality Director to implement process improvements within SMQ and R&D Quality
• Support team activities as needed, including assist with inspections, audits and SMQ project support

Be part of our team

You will join a globally established team, sharing responsibilities with a part-time colleague. Your role will encompass decision-making authority for Observation Research, Patient Support Programs, Market Research and Social Digital Media. Meanwhile, your colleague will handle decision rights for Pharmacovigilance (PV) and Medical Information, Labelling, Regulatory Affairs, Affiliates, and Marketing Partners.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

• Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
• Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP)
• Previous experience supporting regulatory authority inspections of pre-clinical, clinical research, and/or pharmacovigilance activities
• Experience of training and supporting process improvement initiatives
• Previous leadership or mentoring experience is ideal
• Degree educated

THRIVE

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

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.