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- The Senior Manager Quality Assurance (QA) will lead a team of QA staff and provide QA leadership and QA oversight in support of the Plant Quality Assurance (PQA) team members for AR5.
- The Senior Manager QA will report to the Director of Quality Assurance for AR5 and as a member of this leadership team will contribute to fostering and further developing the culture of Safety and Quality at ARI.
- Serve as QA department representative in Global Network meetings and lead cross functional teams at site and cross-site meetings.
- Partner on cross-functional and cross-site teams to develop and implement business processes related to QA process/systems.
- Continuous Improvement – Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Lean Transformation Operational
- Excellence program to develop stronger capabilities in continuous improvement.
- Communicate with all levels of the organization, facilitate development of solutions to critical business issues and define objectives to enable effective metric generation and reporting.
- Quality Oversight and Leadership – Ensures the Quality Management System processes are executed in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, Corrective Actions/Preventative Actions (CAPAs) and Change Controls. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise /
- Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.
- Provide quality assessments and propose strategic direction support defect reduction, improving productivity, reducing lead times and increasing capabilities to achieve organizational success.
- Management of expenditures and work force model criteria to support business initiatives for department, site and organizational needs.
- Fosters a culture that encourages and supports diversity and inclusion.
- Staff Management – Maintains the safety of self and others, actively engages with the Amgen Environmental Health,
- Safety and Sustainability (EHSS) safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen’s talent management program.
- Adapts or shifts priorities in response to the needs of clients, constituents, or the organization.
- Assess, develop, measure and interpret process performance metrics.
Qualification & Experience:
- Associate degree and 10 years of Quality experience
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects,
- programs or directing the allocation of resources
- Master’s degree and 6 years of Quality experience
- Bachelor’s degree and 8 years of Quality experience
- High school diploma / GED AND 12 years Quality experience
- Doctorate degree and 2 years of Quality experience
- Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
- 7+ years’ work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality
- Previous exposure to bulk drug and drug product manufacturing processes and quality assurance processes
- Track record of building or participating as a member of high performing team
- Bachelor’s Degree in Life Sciences or Engineering
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
- Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations
- Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
- Experience in project management, process improvement, and change control
- Experience with manufacturing processes
- Experience in auditing and defending processes, procedures and decisions during regulatory inspections
- Thorough working knowledge of European Union (EU) and United States Good Manufacturing Practices (cGMPs) including computer related systems
Vacancy Type: Full Time
Job Location: Providence, RI, US
Application Deadline: N/A