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.
Senior Manager Quality ControlLive
What you will do
Lets do this! Lets change the world! In this vital role, you will lead a multi-layered team in the Amgen Rhode Island Quality Control organization responsible for in-process, release, and stability testing of Amgen products. The Senior Manager QC will report directly to the Director of Quality Control and as a member of this leadership team will contribute to fostering and further developing the culture of Safety, Quality, and Lean Leadership.
The Senior Manager QC will be accountable for the following functions in support of core QC laboratory operations:
Bio-analytics Testing Teams (General Chemistry, Separation Sciences, Cellular Immunobiology/Bioassay):
- Routine Product Testing (Drug Substance In-Process/Release/Stability & Drug Product)
- Product Testing Disposition Schedule
- Method validations / transfers
- Support troubleshooting and problem solving
- ARA ownership
- Minor deviation initiation and support major deviations as a SME
- Site SMEs for specialized testing
- Document ownership for testing procedures
Quality Control Leadership Team:
- Representation in governance, management review and other forums.
- Innovative projects to advance productivity.
- Compliance with safety guidelines, cGMPs and other applicable regulatory requirements.
- Support staff training, career development and performance management.
- Establish and enable LEAN principles across all areas of responsibility.
- Establish and enable department goals, strategies and KPIs.
- Effectively manages the daily work of direct reports responsible for various QC functions.
- Champions process improvements that have major implications to Laboratory operations as it relates to site production and the Amgen network.
- Mentor employees by sharing technical expertise and providing feedback and guidance.
- Understands business environment and relates extensive knowledge of industry to streamline business processes.
- Interfaces with management on significant matters, often requiring the coordination of activity across organizational units and exercises judgment independently.
- Plans and organizes project assignments of substantial variety and complexity.
- Initiates or maintains schedule to support QC, network and production requirements.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Clearly articulate and educate others sampling, testing and release, sample management, business processes, regulatory and compendia requirements.
- Translates complex data into actionable information and applies strong technical knowledge to meet business objectives Consistently applies a systematic approach and uses exemplary analytical and critical thinking skills for problem solving.
- Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs.
- Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions.
- Generates enthusiasm, energy, and commitment by expressing a compelling idea or goal Seeks out opportunities to permanently improve processes and shares best practices with others.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a strong leader with these qualifications.Basic Qualifications:
- High school diploma / GED and 12 years of related experience OR
- Associates degree and 10 years of related experience OR
- Bachelors degree and 8 years of related experience OR
- Masters degree and 6 years of related experience OR
- Doctorate degree and 2 years of related experience OR
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control.
- Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources.
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners.
- Track record of building or participating as a member of high performing team.
- Experience in leading and owning complex investigations.
- Experience in auditing and defending processes, procedures and decisions during regulatory inspections.
- Experience with various laboratory computer systems and applications.
- Strong leadership and negotiation skills with a demonstrated ability to influence different styles.
- Demonstrated innovative thinking and ability to transform work organizations.
- Strong technical writing skills within a highly regulated environment.
- Exposure to Operational Excellence initiatives.
- Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations.
- Demonstrated ability to navigate through ambiguity and provide structured problem solving.
- Demonstrated ability to coordinate multi-functional project teams and deliver on schedule.
- Demonstrated ability to coordinate and lead cross-functional teams.
- Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization.
- Demonstrated skills in staff motivation, coaching/mentoring and professional development.
- Great teammate who is able to collaborate and provide leadership through influence to achieve the required results.
What you can expect of us
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.
- 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
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
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.