Head of Quality Assurance Scotland - Livingston, United Kingdom - Valneva

Valneva

Verified Company

Livingston, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Please find a link to our corporate video for a quick insight into Valneva

Our Quality Assurance Team have a fantastic opportunity for a QA Manager to join our successful team here in Livingston.

To ensure that Quality Assurance Operations and supporting systems are delivered to support ongoing manufacture, batch release and regulatory requirements in Valneva's new, purpose-built, state-of-the-art vaccines production facility.

Provide QA leadership on continuous improvement of the process and quality standards on site.

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 selfinspection 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 Valneva 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, coordination and implementation of quality improvements
Good understanding and working knowledge of the Pharmaceutical Industry
Previous experience of working to tight deadlines and reprioritising workload
Proven experience of working with operational excellence improvement tools
Experience of leading and delivering quality metrics

Benefits