My client is a growing biopharmaceutical company with strong pipeline and exciting ongoing projects.
Due to this growth my client is looking for a Associate Director QA Biomanufacturing to join their growing biomanufacturing site based in North of Vaud canton.
To be responsible for the Quality oversight of manufacturing, QC testing and warehousing operations.
My client is a growing biopharmaceutical company with strong pipeline and exciting ongoing projects.
Due to this growth my client is looking for a Associate Director QA Biomanufacturing to join their growing biomanufacturing site based in North of Vaud canton.
To be responsible for the Quality oversight of manufacturing, QC testing and warehousing operations.
Responsibilities;
• Manage the QA Operations team in charge of raw material, WCBs, intermediates and drug substance batch records review and release, including deviations, investigations, CAPA, change management and daily oversight of suppliers
• Develop and maintain effective Quality Operations processes
• Manage and Organize the batch record review activities to ensure compliance and timely supply of products
• Quality oversight of process, method validation activities and CPV throughout product lifecycle
• Quality oversight of new product introduction at the site and Tech Transfers
• Drive resolution of major quality issues
• Chair Management Review Boards and Change Review Boards for product related events
• Participate or lead continuous improvement projects
• Lead the Quality Agreements Program with suppliers
• Assess suppliers’ Quality risk levels and ensure risks’ mitigation
• QA representative for periodic management reviews with key suppliers
• Lead or contribute to the elaboration of risk assessments
• Lead the Annual Product Quality Review Process
• Ensure regulatory inspection readiness in area of responsibilities
• Support any Heath Authorities inspections (Swissmedic, FDA and other International Health Authorities) in relation to area of expertise and responsibilities
• Perform self-inspections and audits of suppliers
• Act as QP delegate
• Contribute positively to a strong culture of business integrity and ethics
• At all times work in a right first time and site inspection readiness approaches
• Act within compliance and legal requirements as well as within company guidelines
Your profile:
• Master Degree or PhD in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Biologics, or Pharmaceutical Sciences
• Minimum of 10 years in a Quality Assurance role in a biopharmaceutical or related manufacturing environment
• strong experience in people management
• Thorough knowledge of biotechnology processes
• Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations Proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
• Experience in Health Authorities inspections
• Qualified auditor
• Green belt certification and validation experience would be appreciated
• Good speaking and reading skills in English and French
• Excellent written and verbal communication skills