We are looking for a Head of Quality for our site in Carlsbad, CA which focuses on the manufacturing of clinical viral vaccines and gene therapy vectors. In this role you will be a critical leader of a significant Quality function and will be leading a team with a goal of ensuring that the facility maintains readiness to support FDA and EU licensed products. Another key component of your role will be leveraging your ability to effectively lead a team of around 50 people and facilitate the learning and development opportunities for our QA/QC teams and the greater organization.
Lead, manage and develop the Quality group through periods of rapid change
Drive change through role modeling and continuous improvement
Play a key role on the leadership team advocating for Quality and driving Quality culture
Ensure that direct reports and their teams carry out their duties according to the principles of GMP
Participate in continuous improvement projects and prepare report and present KPI metrics to senior management
Maintain 'audit ready' status at all times and co-ordinate site activities in preparation for regulatory audits
Participate in responses/corrective actions to regulatory findings
Manage and support the systems required to perform the core site activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective & Preventative Actions (CAPAs), investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer enquiries/questionnaires
Perform gap assessments and lead the site implementation of corporate Quality policies.
Prepare appropriate Standard Operating Procedures (SOP) and training modules when required and carry out the training
Assist, when required, in the review and approval of GxP documents, including protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, Validation Protocols, and all other Quality Management System (QMS) documentation
Review and approve executed GxP documents and records.
Participate in the recruitment and development of QA staff, ensuring all team members have appropriate goals and objectives set.
Actively manage the performance and development of teams using available tools and procedures.
Actively promote and demonstrate adherence to Health and Safety policies and practices, acting as a role model for other employees within the organization.
Who You Are:
BS in the Life Sciences, advanced degree preferred
10+ years of hands-on experience in Quality
A minimum of 5 years at a senior level (manager or higher) leading a QA/QC groups in a life science, GMP/FDA regulated industry such as pharma and biopharma. Knowledge and understanding of the viral and gene therapy field is preferred
Proven experience developing teams
Experience with common continuous improvement tools (e.g., six sigma)
Knowledge of Quality Risk Management
Experience leading regulatory inspections and audits
Extensive knowledge of EU/US GMP regulations and related standards
Excellent written and verbal communication/ presentation skills and organizational skills
Logical in thought and detail focused
Proven ability to lead change through an organization
Analytical approach to problem solving and decision making
Job Requisition ID: 179384
Career Level: E - Professional (10+ years)
Working time model: full-time
Job Segment: Quality Assurance, Quality Manager, QA, Six Sigma, Technology, Quality, Management