Senior Manager Quality Assurance - Disposition
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!
Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Responsible for Quality disposition (approval or rejection) of raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas.
Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, and validations.
Supports Continual Improvement initiatives, programs and projects.
Ensures that changes that could potentially impact product quality are assessed according to procedures.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
Collaborates cross functionally and across the Amgen Enterprise/Network to ensures the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations.
Alerts senior management of significant quality, compliance, supply and safety risks.
Represents the quality unit during audits and inspections as needed.
Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
Completes required assigned training to permit execution of required tasks.
Performs additional duties as specified by management.
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:
Doctorate degree and 2 years of Quality experience OR
Masters degree and 6 years of Quality experience OR
Bachelors degree and 8 years of Quality experience OR
Associates degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
5+ years of Quality experience, with at least 2 years of direct Disposition experience.
Experience with the review and Disposition of batches for all phases of drug development.
Experience interacting with multiple sites and QPs.
Solid understanding of GMPs and global QA requirements as related to lot Disposition to US and multiple jurisdictions.
Understanding of the Disposition Process integration with and relationship to other Quality Processes
Previous managerial experience.
Proven leadership and organizational skills.
Skilled in technical writing and critical thinking.
Computer Skills: Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Electronic Document Management System (EDMS).
Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure.
Highly organized and possess excellent attention to detail.
Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
#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.