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For Companies At a Glance
- Tasks: Lead and enhance Amgen's Quality Management System and support the SMQ team.
- Company: Join Amgen, a leading biotech company dedicated to serving over 10 million patients globally.
- Benefits: Enjoy flexible work options, generous rewards, and opportunities for personal and professional growth.
- Why this job: Be part of a diverse team making a real impact in patient care and quality compliance.
- Qualifications: Experience in Quality Management and knowledge of Good Pharmacovigilance Practices required.
- Other info: Work from home with occasional office visits in Cambridge or Uxbridge.
The predicted salary is between 43200 - 72000 ÂŁ per year.
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.
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Senior Manager Quality Compliance employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Quality Compliance
✨Tip Number 1
Familiarize yourself with Good Pharmacovigilance Practices (GPvP) and the latest trends in quality compliance within the pharmaceutical industry. This knowledge will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the biotech and pharmaceutical sectors, especially those involved in quality management and compliance. Engaging with them can provide insights into the company culture at Amgen and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences in training and mentoring, as these are crucial for the Senior Manager role. Think of specific examples where you successfully led initiatives or improved processes.
✨Tip Number 4
Research Amgen's recent projects and initiatives related to R&D Quality Management Systems. Being able to reference these in your conversations will show your genuine interest in the company and its mission.
We think you need these skills to ace Senior Manager Quality Compliance
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Manager Quality Compliance position. Understand the key responsibilities and required qualifications, especially focusing on Good Pharmacovigilance Practices (GPvP) and Quality Management.
Highlight Relevant Experience: In your application, emphasize your experience in Quality Management and Quality Compliance within the pharmaceutical or biotech industry. Be specific about your knowledge of R&D processes and any previous leadership or mentoring roles you've held.
Showcase Training and Development Skills: Since the role involves creating training programs and mentoring team members, make sure to include examples of your experience in training and supporting process improvement initiatives. This will demonstrate your capability to enhance team performance.
Tailor Your Application: Customize your CV and cover letter to reflect the language and values mentioned in the job description. Use keywords related to compliance, audits, and pharmacovigilance to ensure your application stands out to the hiring team.
How to prepare for a job interview at Amgen SA
✨Understand Good Pharmacovigilance Practices (GPvP)
Make sure you have a solid grasp of GPvP and how it applies to the role. Be prepared to discuss your experience with these practices and how they relate to quality compliance in the pharmaceutical industry.
✨Showcase Your Leadership Experience
Highlight any previous leadership or mentoring roles you've held. Discuss specific examples where you successfully guided a team or implemented training programs, as this will demonstrate your capability to manage and develop the SMQ team.
✨Prepare for Regulatory Authority Inspections
Since the role involves supporting regulatory inspections, be ready to talk about your past experiences with such inspections. Share insights on how you contributed to successful outcomes and what you learned from those experiences.
✨Emphasize Process Improvement Initiatives
Discuss any initiatives you've led or participated in that focused on process improvements. Be specific about the challenges faced, the solutions implemented, and the results achieved, as this aligns with the expectations of the role.
