A

Amgen

Makes biotech medicines for serious illnesses

Manager Quality Assurance

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeHolly Springs, NC, USA

About the Job

Requirements

  • High school diploma or GED and 12 years of Quality experience, or an associate’s degree and 10 years of Quality experience, or a bachelor’s degree and 5 years of Quality experience, or a master’s degree and 3 years of Quality experience, or a doctorate degree.
  • Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing resource allocation; managerial experience may run concurrently with the required technical experience.
  • Preferred: A scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
  • Preferred: Experience and training in CDOCS, Trackwise, Maximo, LIMS, MES Werum, and other systems and applications.
  • Preferred: Experience managing multiple competing priorities in a fast-paced environment.
  • Preferred: Experience leading and/or managing teams.
  • Preferred: Proficiency in written and verbal communication, including technical writing and presentations, and ability to communicate and collaborate with technical and senior management staff.
  • Preferred: Quality assurance or combined quality and manufacturing experience in the biotechnology or pharmaceutical industry.
  • Preferred: Experience and systems knowledge in manufacturing investigations, corrective and preventive actions, product release, validation, and/or change control.
  • Preferred: Experience with regulations, standards, and guidelines that apply to biotech manufacturing in a multi-product environment.
  • Preferred: Ability to develop team and staff goals, manage performance, and coach and develop staff.
  • Preferred: Ability to manage timelines and deliver results to meet or exceed department and company goals and objectives.
  • Preferred: Ability to communicate clearly, facilitate discussions, and present to audiences at all levels of a site organization.
  • Preferred: Ability to solve complex problems and evaluate scientific data, with independent, risk-based decision-making ability on the floor to support manufacturing needs.

Responsibilities

  • Oversee ANC startup activities for facilities, utilities, equipment, systems, and processes, integrating them with Amgen Quality Systems.
  • Interview candidates to build the ANC Plant Quality Assurance team.
  • Author, review, and approve quality documents, including standard operating procedures, user requirements, risk assessments, training materials, engineering and automation documents, commissioning test protocols and reports, environmental and utility qualification protocols and reports, and validation protocols and reports.
  • Oversee execution of and change management for factory acceptance, commissioning tests, facility qualifications, and validation activities.
  • Manage the Plant Quality Assurance staff and daily operations, including training verification, schedules, ongoing tasks, prioritization, and support needs.
  • Oversee staff and team performance, prioritize staff development, and provide ongoing development support.
  • Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices, Good Documentation Practices, and other applicable regulations.
  • Participate in inspection-readiness activities to ensure facilities, equipment, materials, organization, processes, and procedures comply with current Good Manufacturing Practices and other applicable regulations.
  • Develop or contribute to procedures and standards by which others will operate.
  • Develop and communicate goals and objectives to staff and key partners.
  • Monitor goal performance and coordinate improvement actions for team and overall Plant Quality Assurance performance by championing department operational excellence and Lean efforts.
  • Assist project teams in establishing priorities and project timelines and securing resources.
  • Represent Quality Assurance on incident triage teams or support efforts by providing guidance and 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, environmental characterization reports, and change-control documents.
  • Support site audits and inspections.

Desired Qualifications

  • Experience and training in CDOCS, Trackwise, Maximo, LIMS, MES Werum, and other systems and applications.
  • Experience managing multiple competing priorities in a fast-paced environment.
  • Experience leading and/or managing teams.
  • Proficiency in written and verbal communication, including technical writing and presentations, and ability to communicate and collaborate with technical and senior management staff.
  • Quality assurance or combined quality and manufacturing experience in the biotechnology or pharmaceutical industry.
  • Experience and systems knowledge in manufacturing investigations, corrective and preventive actions, product release, validation, and/or change control.
  • Experience with regulations, standards, and guidelines that apply to biotech manufacturing in a multi-product environment.
  • Ability to develop team and staff goals, manage performance, and coach and develop staff.
  • Ability to manage timelines and deliver results to meet or exceed department and company goals and objectives.
  • Ability to communicate clearly, facilitate discussions, and present to audiences at all levels of a site organization.
  • Ability to solve complex problems and evaluate scientific data, with independent, risk-based decision-making ability on the floor to support manufacturing needs.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

Recently Posted Jobs

Explore more opportunities at Amgen

See more jobs