Assistant Manager jobs in United States

Quality Assurance Team Leader

An established and growing pharmaceutical contract manufacturing organisation in the North West is seeking an experienced Quality Assurance Team Leader to oversee QA operations, lead a team of QA Officers / Senior QA officers, and ensure compliance with regulatory requirements. Reporting directly to the Quality Director, this role offers the opportunity to take ownership of operational quality. The ideal candidate will have a strong background in GMP-regulated environments, with hands-on experience in batch review, CAPAs, investigations, QMS management, and validation activities.

• Lead and manage the QA Operations team, providing coaching, support, and effective line management.
• Oversee QA workload to ensure right-first-time manufacture, testing, and timely product release.
• Manage quality approval of materials, components, and bulk products, liaising with suppliers and contract laboratories.
• Oversee and develop the Supplier Assurance Programme, including supplier audits, qualification/requalification, and non-conformance resolution.
• Conduct a thorough review of batch documentation, supporting product release in compliance with GMP, ISO13485, and Annex 16.
• Lead and support investigations into deviations, OOS results, and customer complaints, driving effective CAPA implementation.
• Maintain and update the Quality Management System (QMS), ensuring compliance with regulatory standards and supporting continuous improvement.
• Contribute to QA validation activities, including review and approval of protocols, reports, and equipment qualification documentation.
• Manage and review the Environmental Monitoring programme, including risk assessments of out-of-limit events.
• Ensure product specifications, artwork, and quality documentation are appropriately controlled and updated.
• Support new product introductions, embedding quality requirements into processes.
• Lead internal audits, support external inspections, and ensure ongoing inspection readiness.
• Author, review, and approve GxP documentation, including SOPs, batch records, and validation reports.
• Provide proactive QA support across manufacturing, packaging, warehousing, and other operational areas.
• Promote a strong quality culture across the site, driving compliance and continuous improvement.

• Significant experience in pharmaceutical or life sciences Quality Assurance within a GMP-regulated environment.
• Strong knowledge of GMP, ISO13485, Annex 16, and relevant regulatory frameworks.
• Practical experience in batch documentation review, CAPA management, deviation and OOS investigations, change controls, and supplier audits.
• Exposure and understanding of QA validation activities
• Excellent communication skills, able to influence and collaborate effectively across all levels of the business.
• Strong organisational and problem-solving abilities with a proactive, pragmatic approach.

• Competitive salary (£40,000 - £50,000 depending on experience).
• Opportunity to take ownership of QA operations within a collaborative and growing organisation.
• Clear scope for career progression and professional development