Job Description: 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. Job Responsibilities: 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 Job Details: Company: Amgen Vacancy Type: Full Time Job Location: Providence, RI, US Application Deadline: N/A Apply Here vacancyoptions.com
Latest Job Vacancies in the USA, UK and Worldwide
