Senior Manager Quality Assurance

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.

Responsibilities:

• 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.
• 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.
• 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.
• 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.
• Provide quality assessments and propose strategic direction support defect reduction, improving productivity, reducing lead times and increasing capabilities to achieve organizational success.
• 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.
• Assess, develop, measure and interpret process performance metrics.
• 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.
• Adapts or shifts priorities in response to the needs of clients, constituents, or the organization.

Basic Qualifications

• Doctorate degree and 2 years of Quality experience
• OR
• Master's degree and 6 years of Quality experience
• OR
• Bachelor's degree and 8 years of Quality experience
• OR
• Associate degree and 10 years of Quality experience
• OR
• High school diploma / GED AND 12 years Quality experience
• AND
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Bachelor's Degree in Life Sciences or Engineering
• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Track record of building or participating as a member of high performing team
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• 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
• Experience with manufacturing processes
• Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations
• Previous exposure to bulk drug and drug product manufacturing processes and quality assurance processes
• Thorough working knowledge of European Union (EU) and United States Good Manufacturing Practices (cGMPs) including computer related systems
• Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
• Experience in project management, process improvement, and change control
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule
• Demonstrated ability to coordinate and lead cross-functional teams
• Demonstrated ability to deliver results through living the Amgen values

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.

Join Us

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.