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.
Manager Quality AssuranceLive
What you will do
Lets do this! Lets change the world! In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner. This includes partnership between Manufacturing, F&E and Quality staff providing coaching, guidance and direction in regards to deviations, quality systems and compliance.
This role will be assigned a day-shift schedule; Reporting staff will be working a 7am-7pm rotating shift schedule to cover all 7 days per week.
- Manage a team of PQA staff and perform managerial duties including: human resources, staff/team performance, and staff development.
- Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
- Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
- Independently determine approach to managing daily operations; guided by general policies and management guidance
- Develop or contribute to the development of procedures and standards by which others will operate.
- Develop and communicate goals and objectives to staff and key partners
- Monitor goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources.
- Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership
- Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change
- Review and approve operational and product manufacturing procedures, process validation protocols and reports for manufacturing processes, environmental characterization reports and change control documents.
- Approve deviations, representing QA on project teams and approving change-over completion controls.
- Oversee and provide guidance during on-the-floor analytical testing.
- Lead and/or support audits, inspections and investigations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is an outstanding communicator with these qualifications.
- High school diploma / GED and 12 years of Operations / directly-related experience OR
- Associates degree and 10 years of Operations / directly-related experience OR
- Bachelors degree and 5 years of Operations / directly-related experience OR
- Masters degree and 3 years of Operations / directly-related experience OR
- Doctorate degree
- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
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.