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Head Of Quality

Expired Job

EMD Millipore Carlsbad , CA 92008

Posted 6 months ago

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.

Your Role:

  • 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

Location: Carlsbad

Career Level: E - Professional (10+ years)

Working time model: full-time

Job Segment: Quality Assurance, Quality Manager, QA, Six Sigma, Technology, Quality, Management

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Head Of Quality

Expired Job

EMD Millipore