Manager Quality Control
Job ID: R-103996
Location: West Greenwich, RI, US 02817
The Manager Quality Control (QC) position will supervise a team responsible for QC Equipment Management at Amgen Rhode Island and will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.
The Manager QC will contribute directly and provide oversight to a team responsible for the following functions in support of core QC laboratory operations:
- End to end life cycle for QC equipment, including the procurement, development of validation and change control strategy/ownership, oversight of preventive maintenance activities, and decommissioning.
- Site SME/Representative on QC System Owner Network (fields requests/provides advice to other sites, alignment decisions with other sites)
- Document ownership of Master List QC Equipment, QC and Manufacturing Computerized Analytical Lab Systems List
- Quality review Data Integrity Assessments for computerized systems and Function Tests done by Automation (alarm changes, graphic changes, and parameters)
- Align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls
- Doctorate degree
- Master's degree and 3 years of Quality or Equipment Management experience
- Bachelor's degree and 5 years of Quality or Equipment Management experience
- Associate's degree and 10 years of Quality or Equipment Management experience
- High school diploma / GED and 12 years of Quality or Equipment Management experience
- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
- Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
- Experience with equipment procurement and development of validation, as well as general and preventive maintenance activities
- Excellent interpersonal, written and verbal communication skills with all levels within the organization
- Ability to work in a team matrix environment and build relationships with partners
- Identify, manage, and champion innovative projects to advance efficiency and enable LEAN principles across different functions
- Experience with supporting staff training, career development and performance management
- Establishment and tracking of department goals, strategies and KPIs
- Experience in auditing and defending processes, procedures and decisions during regulatory inspections
- Experience with various laboratory equipment and computer systems
- Strong leadership and negotiation skills with a demonstrated ability to influence different styles
- Proven innovative thinking and ability to transform work organizations
- Exposure to Operational Excellence initiatives
- Demonstrated ability to coordinate multi-functional project teams and deliver on schedule
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 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.
If 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.