QA Project Manager II, Inspections and Audits
101 International Drive Portsmouth, NH 03801 US
The QA Compliance Project Manager 2 is responsible for supporting the implementation and execution of the Annual Quality and Internal Audit plans; PQR SME support as required; supporting internal/global, customer, and regulatory inspection programs. Managing assigned activities to ensure timely closure of Quality System, and that compliance risks are communicated in a timely manner. Works closely with site leadership and customers to implement effective corrective and preventive actions in response to deficiencies. Supports and pursues continuous improvement and promotes a strong culture of quality awareness and GMP compliance.
- Act as an Auditor in the planning and performance of assigned internal audits. As part of audit planning, review recent trends and areas of concern, prepare audit checklists and the audit agenda.
- As an Auditor, support opening and closing meetings and communicate concerns to the departments in scope.
- Provide input to and/or write supporting documentation for the audit report. The Specialist can identify a compliance issue, and will have an understanding of GMP implications. Review, follow up on, and approve audit responses. Escalate issues to supervisor when needed.
- Author and/or contribute to the writing of the Annual Quality Plan (AQP) and Annual Internal Audit Plan, as assigned.
- Lead projects; define project plan, scope, and deliverables, as assigned.
- Develop training materials for department and site personnel, as assigned.
- Mentor and train other QA Specialists in all aspects of the role.
Customer audits, regulatory inspections, and Lonza Global compliance audits:
- Act as Back Room Manager or Back Room staff.
- Liaise with the site to fill front room requests from hosts. Disseminate information effectively or support in the front room if appropriate.
- Coach SMEs on the appropriate interaction with the front room. Aid in the success of audits and inspections by appropriately triaging information.
- Aid in the set-up and break down of the front room and back room and audit materials