The Quality Assurance Manager department leads a team of QA Specialists as they support internal customers with interpretation and application of Lonza policies and procedures with regard to GMP Documentation and related Quality projects. The manager of this team is the Subject Matter Expert for quality and compliance review and approval of Standard Operating Procedures, Technical Documents, Annual Product Reviews, Master Batch Records, and Quality Agreements. The manager trains the team and leads them in providing support and quality reviews. The manager leads the process for delegation of documents and meeting timelines.
Provide general direction for department. Develop team goals and ensure continuous improvement, team efficiencies, innovative thinking and track progress to final approval. Oversee training, mentor and develop in Quality principles. Conduct objective setting and regularly scheduled sessions with individuals of team to review objectives, provide feedback and provide guidance for personnel advancement. Interview and hire personnel to provide responsible, experienced people to carry out job function.
Develop, direct, and maintain the local Quality Systems at Portsmouth and contribute to the review of global quality systems in line with Lonza Corporate requirements and standards and current regulatory requirements, meeting US FDA and European requirements, and others as needed for cell therapy products.
Review and approve Lonza policies, SOPs, Batch Records, Process Descriptions and forms with in Document Management System. Responsible to ensure changes are justified; procedures are followed and contain appropriate associated references.
Manage and track performance indicators and represent department at site meetings and attend other meetings with requested
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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