HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Specialist - Quality Systems and External Affairs (Remote) Live
What you will do
Lets do this! Lets change the world! In this vital role, you will manage and lead projects for Amgen's External Affairs Department, globally. You will be the liaison between Amgen and peers in other companies with the goal to gain knowledge/understanding of standard processes to facilitate continuous improvement. This position leads project management of Amgens Good Clinical, Laboratory, and Manufacturing Practices (GxP) Intelligence, and Competitive Intelligence (CI) with focus on operations and GMP/GDP; and will also network across various Amgen functions including: GRAAS-CMC and R&D Policy, Governmental Affairs, quality & supply chain, manufacturing/development sites and other affiliates (as appropriate).
- Gain knowledge internally and externally regarding early signals, current hot topics, and evolving issues impacting Amgen Operations globally and in designated region/countries.
- Set up, lead, and improve related data bases in External Affairs.
- Conduct assessments, analysis of data sources, and communication back into the organization through established channels.
- Work internally to gain alignment, support, and scientific knowledge on related developments in external landscape.
- Represent Amgens approved positions in appropriate external organizations (e.g., PhRMA and/or EFPIA and/or BIO and/or PDA) by crafting the external environment including related policy initiatives.
- Liaise with regulators facilitated by industry associations, as assigned.
- Undertaking additional projects with focus on accountabilities or development opportunities, as applicable.
- Provide support and act as backup to one another position in External Affairs.
- Travel in country and internationally as required to fulfill the company needs (approx. up to 15%).
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The detail focused professional we seek is an excellent communicator that has strong customer relation skills, with these qualifications.
- Doctorate degree and 2 years of Scientific/Quality Management experience OR
- Masters degree and 6 years of Scientific/Quality Management experience OR
- Bachelors degree and 8 years of Scientific/Quality Management experience OR
- Associates degree and 10 years of Scientific/Quality Management experience OR
- High school diploma / GED and 12 years of Scientific/Quality Management experience
- Bachelors Degree in Science or equivalent, advanced degrees preferred.
- Ability to interpret, synthesize, and communicate information, not simply summarize.
- Creative and independent thinker.
- Ability to establish relationships and use influence effectively in a variety of settings, both within the company and with external organizations including regulators, public officials, trade associations and other relevant parties.
- Possesses unquestionable integrity and a sense of confidence, balanced with modesty.
- Experience in leading external organization topic teams such as PhRMA, PDA, etc. preferred.
- Recognized as a speaker at internal meetings / conferences on current Quality / CMC topics.
- Excellent English communication and presentation skills (both written, visual and oral).
- Understanding of global regulatory and quality requirements focused on GMP/GDP, QMS, supply chain and potentially also CMC.
- Specific knowledge in current regulatory GMP/GDP, CMC trends and related topics.
- Potentially performed in the area in focus of the job description.
- Ability to understand technical, scientific, and medical information.
- Some experience in working with and representing a company in external organizations.
- Must have the ability to work in a team cross-functional matrix environment and independently interact with various levels of management and regulators.
- Excellent communication skills, both written and oral, are crucial.
- Able to work under pressure, with changing priorities and outside office hours as part of team based in different continents.
- Languages: proficient in English (written and spoken); potentially a second language.
- Ability to develop applications, and maintain databases.
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 maximize 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf 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.