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Senior Manager Quality Compliance
Apply remote type Flex Commuter / Hybrid locations United Kingdom - Cambridge United Kingdom - Uxbridge United Kingdom - London time type Part time posted on Posted 2 Days Ago job requisition id R-207840
Career Category
Quality
Job Description
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.
About Us
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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