Our client is a biotech company focused on the development and commercialization of vaccines for infectious diseases with significant unmet medical need. We are looking for an experienced QA Manager for a Head of QA opportunity.
Requirements
- Recruit, lead, manage and develop the Quality Assurance department staff and manage the organisational structures, policies, procedures and processes necessary to ensure effective, efficient and accountable use of these resources
- Assure compliance to all facilities, systems, processes and best work principles by maintaining a thorough quality oversight of internal site operations needed for the product manufacturing, testing and release
- Work with other senior QA management on site, to develop, monitor, improve and maintain procedures to ensure compliance with EU / FDA Good Manufacturing Practice and Good Distribution Practice for the manufacture and testing of pharmaceuticals
- Drive and oversee that deviations, changes and CAPAs related to materials, facilities, processes or procedures are being escalated and addressed in an appropriate and timely manner for the area of responsibility
- Drive and oversee that the self-inspection and external audit systems to ensure that the site systems and processes for audits are delivered to support compliant business operations. Ensure key quality metrics for the Audit programs are available to management to drive continuous improvement and compliance with current regulations, quality requirements and business needs
- Provide QA leadership for audit / regulatory inspections: lead site readiness planning, hosting and ensuring timely response and close out
- Providing QA leadership on the compliant delivery of key investigations
- Manage and where applicable perform documentation reviews in accordance with relevant Standard Operating Procedures, including but not limited to:
- CAPA
- Change Requests
- Deviations (including Quality Investigations and OOS)
- Product Technical Complaints
- QMS data logs
- Room Release documentation
- Batch record review (including PPRs, PTRs, MPRs and SPRs)
- Fill / finish documentation
- Oversee batch release duties in accordance with relevant procedures, including issuing Certificates of Conformance for bulk drug product
- Be accountable for on time document management and performance measurement
- Deliver the requirements of the Quality Review Board (QRB) and local QA governance Quality requirements reporting on Quality Issues, escalating to QRB and Global Quality Governance Bodies, as required
- To immediately escalate any material breach of quality or regulatory compliance matters to the Site Director, Director of Quality Operations and Qualified Person(s)
- Actively contribute to deliver the Quality strategy for the delivery of business effective compliant systems to support the operations and site processes
- Support the site QP(s) in the delivery of systems and batch documents which meet the requirements for batch release to market
- To deputise where appropriate and undertake any other reasonable duties as requested by the Director of Quality Operations, in accordance with company requirements
- Shift work and out of hours work as required
Experience
- Degree level education or equivalent experience
- Relevant and proven experience in an operational management role, operating to GMP / GDP standards and regulatory expectations
- Experience of EU / FDA and cGMP / GDP requirements for the manufacture and testing of biological products
- Experience in the planning, co-ordination and implementation of quality improvements
- Good understanding and working knowledge of the Pharmaceutical Industry
- Previous experience of working to tight deadlines and re-prioritising workload
- Proven experience of working with operational excellence improvement tools
- Experience of leading and delivering quality metrics
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