Head of Quality Assurance

International Manufacturer of Vaccines, Located in West Lothian, are Seeking to Appoint a Head of QA to Lead an Established Team of QA Scientists at a New, Purpose-Built, State-of-the-Art Vaccines Production Facility in Scotland

Demonstrable Strong Leadership Skills are an Essential Requirement of All Applicants

ROLE

• Reporting to the Director of Quality Operations, the Head of Quality Assurance, will Ensure that QA Operations and Supporting Systems are Delivered to Support Ongoing Manufacture, Batch Release and Regulatory Requirements and will Provide QA Leadership on Continuous Improvement of Process and Quality Standards
• Recruit, Lead, Manage and Develop the QA Department Staff and Manage the Organisational Structures, Policies, Procedures and Processes Necessary to Ensure Effective, Efficient and Accountable Use of 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 CAPA’s Related to Materials, Facilities, Processes or Procedures are Escalated and Addressed Appropriately and Timely
• Drive and Oversee Self-Inspection and External Audit Systems to Ensure Site Systems and Processes for Audits are Delivered to Support Compliant Business Operations
• Ensure Key Quality Metrics for 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 eg Lead Site Readiness Planning, Hosting and Ensuring Timely Response and Close Out

REQUIRED (Essential)

• Degree Level Education in Appropriate Subjects
• Good Understanding and Working Knowledge of the Pharmaceutical Industry
• 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 Manufacture and Testing of Biological Products
• Experience of Direct Regulator Interface relative to Facility Inspections
• Experience in Planning, Co-Ordination and Implementation of Quality Improvements
• 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
• Demonstrable Strong Leadership and Change Management Skills and Experience

REQUIRED (Desirable)

• Experience of Working with Biologicals/Vaccines

REMUNERATION

• £70K p/a + Range of Benefits

RESPOND

• Call Luke Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail Luke@ARxConsultancy.com with Your Application, Including Your Current CV