Manage and report all Quality Metrics for the Molecular Cell Biology team鈥攊ncluding Exceptions, CAPAs, Change Controls, and SOPs鈥攅nsuring all actions are assigned, tracked, and closed in line with company compliance requirements.
Review and approve all relevant Quality documentation for the Molecular Cell Biology department, such as Exceptions, CAPAs, SOPs, and quality/technical agreements.
Lead and participate in cross鈥慺unctional risk assessments as required.
Support and lead problem鈥憇olving activities within the department, ensuring effective collaboration across functions.
Ensure processes and systems are in place to complete Quality- and CAPA鈥憆elated project work and produce customer reports in a timely manner.
Provide continuous feedback to team members regarding customer expectations, quality requirements, and process changes.
Manage the completion of compendia update assessments for the department.
Support department leadership in maintaining the quality of daily laboratory work and collaborate with team members to resolve any quality-related issues.
Manage assigned customer queries, lead complaint investigations, and work with the team to identify and resolve root causes.
Support internal and external/regulatory audits, including preparation, participation, responding to audit queries, and driving corrective actions to closure.
Represent the Molecular Cell Biology department at Change Control Review Boards and equipment meetings, ensuring actions are assigned and tracked appropriately.
Approve and maintain up鈥憈o鈥慸ate laboratory SOPs within your area of responsibility.
Identify opportunities to enhance quality, efficiency, and customer service, and support the implementation of continuous improvement initiatives.
Establish and monitor key metrics related to quality and customer satisfaction/delivery, ensuring targets are met and trends are proactively addressed.
Ensure all team documentation is accurate, complete, up to date, and compliant with company procedures.
Communicate regularly with the team and supporting departments to ensure effective information flow throughout the organisation.
Provide coaching and mentoring to improve understanding and compliance with quality standards.
Review data in accordance with regulatory requirements, analytical procedures, and documentation standards.
Review and accurately prepare reports for technological projects, ensuring confidentiality and timely delivery to clients.