Manager, Quality Assurance

Company: Amgen
Location: West Greenwich
Posted on: May 8, 2022

Job Description:

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.Manager, Quality AssuranceLiveWhat you will doLets 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.Additional Responsibilities:

• 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
• Interpret and execute standards and procedures directly affecting work activities
• 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 procedures, product manufacturing procedures, process validation protocols
• Authorize environmental characterization reports and change control documents
• Approve non-conformances, representing QA on project teams and approving change-over completion controls
• Lead investigations, as well as lead plant and site auditsThis position will be responsible for shifts 2 and 3. Shift 2 is 1 pm - 11 pm, and shift 3 is 10 pm - 8 am. Hours worked will be determined depending on need.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a strong leader with these qualifications.Basic Qualifications
  • Doctorate degree OR
  • Masters degree and 3 years of Quality experience OR
  • Bachelors degree and 5 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 resourcesPreferred Qualifications
    • Bachelors Degree in Life Sciences, Engineering or related field
    • 6 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
    • 3 + years of supervisory/management experience
    • Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control
    • Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment
    • Ability to develop meaningful team and staff goals, manage performance and coach and develop staff
    • Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives
    • Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations
    • Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization
    • Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs
    • Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturingThriveSome of the vast rewards of working hereAs 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 GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com

Keywords: Amgen, Warwick , Manager, Quality Assurance, Executive , West Greenwich, Rhode Island