Partnership Quality Mgr
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!
In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and forward-thinking scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.
The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners.Responsibilities include:
Responsible for leadership and coordination of Quality as needed across Amgen, for interactions with business partners, Amgen sites, and corporate business units.
Lead strategic negotiation, development and ongoing oversight of high-impact partnerships and alliances from a Quality perspective.
Negotiate Quality Agreements and participate in the negotiation of relevant Supply agreements to ensure appropriate Quality requirements are defined.
Participate in regulatory inspections as necessary relating to partnerships/alliances to ensure successful business outcomes.
Coordinate and facilitate partner visits by business partner Quality representatives.
Coordinate specific activities relating to audits of Amgen by business partners.
Lead and manage partner Quality forums and Partner Annual Reviews.
Collaborate with Business Development partners to ensure business priorities are successfully executed against.
Participate in the development of new partner strategic plans and participating in the execution of application tasks to successfully accomplish project goals.
Develop strong partnership with internal manufacturing network and relevant contract manufacturing sites to ensure alignment.
Liaise with peers within the Quality organization to ensure continued evolution of Amgens Quality system are aligned with developing partnership and alliance needs.
Responsible for the execution of projects necessary to achieve to achieve corporate and departmental goals.
Ability to conduct and act upon thoughtful risk analysis. Knowledge of continuous improvement principles and experience in implementing continuous improvement efforts across a distributed team.
Establish standard methodologies for completion of key tasks and drive continuous improvement activities.
Travel both domestically and internationally about 15%Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:
Masters degree and 3 years of Quality experience
Bachelors degree and 5 years of Quality experience
Associates degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
Staff member at GCF level 5
5 years experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry
Experience involving the development of Quality Agreements and relationships with globally diverse partners
Work in a team matrix environment and independently interact with various levels of management
Direct experience with bulk manufacturing of biopharmaceuticals
Demonstrated proficiency leading negotiations
Excellent communication skills, both written and oral,
Knowledge of Quality Assurance functions and practices
Ability to evaluate and lead negotiations around Quality Agreements
Experience in project management (managing projects, defining scope, tracking achievements)
Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
Appropriate cultural awareness and ability to work effectively with those from other cultures/countries
Some of the vast rewards of working here
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.
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
Objects in your future are closer than they appear. Join us.
careers.amgen.com#Operations21Equal 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.
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.