Manager, Quality Systems
Vor 2 Tagen
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
- The Quality Systems Manager will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing
- Own all elements of the process including relevant procedures / forms, training materials, share point content, metrics where applicable
- Display technical knowledge of the process and understand risks/weaknesses in the system
- Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with Bristol Myers Squibb (BMS) policies / directives where applicable
- Responsible for ensuring the elements of the process are current and reflect current practices
- Regularly review the process (trends metrics, trends observations, RFT, Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
- Own relevant process issues - speak to trends / issues / exceptions at External Manufacturing (ExM) Tier 3 Quality Council
- Own Health Authority commitments related to the process
- Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
Processes include Deviation Investigations, Corrective and Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections & Supplier Management.
**Operations Support**
The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
- Processing of Customer Complaint records, including escalation of expedited complaints
- Support the processing of deviation investigations, CAPAs and change controls.
- Perform initial impact assessment of Global change controls that may impact ExM Operations
- Participate in Virtual Plant Team (VPT) meetings as appropriate
- Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required.
- Facilitate tracking of CMO Health Authority inspection observations and CAPAs.
- Escalate any emerging trends / issues to the VPTs, as required.
Support metrics collection and processing, including:
- Capture and report on Quality data and metrics for management review and other organizational forums.
- Utilize data analysis or software skills to build on existing tools to improve the quality system processes.
- Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyse data and information.
Other ad-hoc duties will be required which will include, but not be limited to, the following:
- Act as team lead for coordinator of work associated with complaints, change control and document management in the applicable ExM location
- Author, review and approve Quality Management System (QMS) documents
- Process QMS documents in the electronic document management system
- Participate in and support Permanent Inspection Readiness activities
- Maintain the Quality Risk Register for ExM
- Monitor the periodic review of Quality Systems documents
- Maintain the system and process for record management
- Maintain the system for update of ExM GxP (Good Practice) Authorizations
- Act as facilitator and reviewer of global procedural updates through the GPO network
- Act as ExM Quality Systems representative on ExM and Global Quality projects
- Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits
- Support preparation of and participate in Quality Council meetings
- Perform self-inspection audits as part of the audit team
- Review regulatory inspection observations from other BMS sites for site compliance
- Identify and implement continuous improvement opportunities for Quality Systems owned processes
- Act as qualified training for Quality Systems owned processes
- There will be 5% travel associated with this role.
**Essential**:
- Works under minimum supervision and exhibits a positive work attitude and high productivity
- Detail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skills
- Excellent interpersonal skills
- Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated
- Strong presentation skills; confident public speaker
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