United States, Portsmouth (New Hampshire)
Summary The Quality Assurance Manager, Site Operations Manager 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.
Responsibilities - Provides 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.
- Present and defend the Cleaning Validation program and acceptance criteria to Clients and Regulators.
- Review and revise 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.
- Utilizing an identified standard, independently review and approve in a Document Management System initial version and revised documents such as SOPs, Work Instructions, Forms & Checklists, Scanned Documents and others as needed.
- Review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for
- Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.
- Review and approve 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), etc.
- Attends Change Control Committee, Deviations Review Board and CAPA Board meetings as needed.
- Attends Site Quality Council and Lot Disposition meetings Quality Leadership meetings.
- Manages and tracks Key Performance Indicating Quality Metrics including batch release information for senior site management.
- Manages and leads (mammalian) Performs Lot Release/Disposition activities.
- Identifies and implements improvements to quality processes.
- Provides general direction for department. Develops team goals,
- monitors progress and ensures continuous improvement.
- Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.
- Participates in the hiring process, provides performance feedback,
- coaches, mentors and supports career development.
- Supports Regulatory and Customer Audits as needed.
- Perform other duties as assigned.
Qualifications - Bachelor's Degree with 3 years exposure to a GMP regulated environment.
Reference: R62873