Lonza Group Ltd.
Quality Assurance Manager, Site Operations
Lonza Group Ltd., Portsmouth, New Hampshire, United States, 00215
Quality Assurance Manager, Site Operations
Locations: US - Portsmouth, NHTime Type: Full timePosted on: Posted 3 Days AgoJob Requisition ID: R62873SummaryThe Quality Assurance Manager, Site Operations leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation, and QC functions as well as product disposition. The QA Manager ensures staff is meeting objectives and deliverables on time and in full and plays a key role within the site leadership team. This position supports the overflow of tasks as needed, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance.ResponsibilitiesProvides general direction and support and acts as a point of escalation for QA staff and customers.Ensures objectives are met and expectations align with Lonza SOPs and regulatory requirements.Presents and defends the Cleaning Validation program and acceptance criteria to Clients and Regulators.Reviews and revises the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.Utilizes an identified standard, independently reviews and approves in a Document Management System initial version and revised documents such as SOPs, Work Instructions, Forms & Checklists, Scanned Documents, and others as needed.Reviews and approves electronic and/or paper Validation/Qualification documents such as Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.Reviews and approves non-DMS documents (QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrument Data Sheets, Functional Equivalent Memos, DMS Withdrawal Forms, Periodic Review Audit Trail, and Misc. Facility Forms).Attends Change Control Committee, Deviations Review Board, and CAPA Board meetings as needed.Attends Site Quality Council and Lot Disposition meetings.Manages and tracks Key Performance Indicating Quality Metrics including batch release information for senior site management.Manages and leads (mammalian) Lot Release/Disposition activities.Identifies and implements improvements to quality processes.Provides general direction for the department, develops team goals, monitors progress, and ensures continuous improvement.Conducts regularly scheduled 1-on-1 meetings with staff and conducts regular team meetings to review objectives, provide support and feedback, and assist in resolving issues.Participates in the hiring process, provides performance feedback, coaches, mentors, and supports career development.Supports Regulatory and Customer Audits as needed.Performs other duties as assigned.QualificationsBachelor's Degree with 3 years exposure to a GMP regulated environment.
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Locations: US - Portsmouth, NHTime Type: Full timePosted on: Posted 3 Days AgoJob Requisition ID: R62873SummaryThe Quality Assurance Manager, Site Operations leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation, and QC functions as well as product disposition. The QA Manager ensures staff is meeting objectives and deliverables on time and in full and plays a key role within the site leadership team. This position supports the overflow of tasks as needed, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance.ResponsibilitiesProvides general direction and support and acts as a point of escalation for QA staff and customers.Ensures objectives are met and expectations align with Lonza SOPs and regulatory requirements.Presents and defends the Cleaning Validation program and acceptance criteria to Clients and Regulators.Reviews and revises the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.Utilizes an identified standard, independently reviews and approves in a Document Management System initial version and revised documents such as SOPs, Work Instructions, Forms & Checklists, Scanned Documents, and others as needed.Reviews and approves electronic and/or paper Validation/Qualification documents such as Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.Reviews and approves non-DMS documents (QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrument Data Sheets, Functional Equivalent Memos, DMS Withdrawal Forms, Periodic Review Audit Trail, and Misc. Facility Forms).Attends Change Control Committee, Deviations Review Board, and CAPA Board meetings as needed.Attends Site Quality Council and Lot Disposition meetings.Manages and tracks Key Performance Indicating Quality Metrics including batch release information for senior site management.Manages and leads (mammalian) Lot Release/Disposition activities.Identifies and implements improvements to quality processes.Provides general direction for the department, develops team goals, monitors progress, and ensures continuous improvement.Conducts regularly scheduled 1-on-1 meetings with staff and conducts regular team meetings to review objectives, provide support and feedback, and assist in resolving issues.Participates in the hiring process, provides performance feedback, coaches, mentors, and supports career development.Supports Regulatory and Customer Audits as needed.Performs other duties as assigned.QualificationsBachelor's Degree with 3 years exposure to a GMP regulated environment.
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