Maintain systems for checking and verifying process compliance, including but not limited to SPC, HACCP, SQF, Quality Systems, and Formula Control to provide production departments with tools necessary for daily operations
Ensure that work/escalated issues are addressed and completed in a timely manner and that delays and revised time frames are communicated
Lead, participate, or support activities of committees such as the Supplier Qualification Committee, the EM Task Force, and the Specification Committee
Lead or support audits of suppliers and contract laboratories.
Monitor the performance of the Quality Management System (QMS), producing data, and measuring quality operations against the set standards.
Coordinate and supervise activities required to meet quality standards.
Lead the preparation for audits from external parties and conducting the audit, coordinating the response, and following up to ensure that the CAPA plan is carried out within the specified timescales.
Lead the preparation for regulatory inspections, working with other relevant staff to prepare the response and ensure the on-time closure of applicable CAPA plans.
Plan and perform internal audits of the processes and provide formal written feedback to include guidance on corrective and preventive actions (CAPA) to address any non-compliance with procedures and/or regulations.
Conduct external audits, e.g., third-party service providers, to assess the quality of work, identify potential risks, and support vendor selection.
Develop, review, and implement SOPs, as required.
Requirements
PhD or a Master's degree in a related field (Science), or equivalent work experience and 5+ years of experience in QA.
Excellent verbal and written communication skills with the ability to work with cross-departmental functions including regulatory affairs, department leads, and end users.
Excellent data collection and analysis skills.
Experience with software as a medical device (FDA and ISO).
Pharmaceutical or medical device experience is a plus.
