Our Gene Therapy Client is creating future cell therapy miracles together. They are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products.
In this role, this person will be responsible for management of the Microbiology program at the facility, for completion of quarterly and annual environmental monitoring report, data reviews and approvals and external laboratory management. Supports in-house microbiology testing. Supervises QC Microbiology Supervisors. Provides cross departmental support, as well as, collaborates with other departments to support organizational and functional strategy. Develops and/or revises policies and procedures in support of operational excellence initiatives. Represents Microbiology in internal and external audits which may include interaction with regulatory health authorities and clients.
Job Responsibilities

• Functions as the site Microbiology partner, in collaboration with other stakeholders, ensuring microbiology standards are enforced.
• Coordinates the investigation and closure of deviations with effective root cause analysis.
• Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored and effectiveness checks are completed.
• Approves documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
• Approves and delivers quarterly and annual environmental monitoring reports; Develops continuous improvement plans or actionable deliverables. Participates in the execution of quality system improvement programs and initiatives.
• Perform monthly environmental data review.
• Manage electronic MODA system.
• Support insourcing projects and validations to meet timelines and ensure compliance.
• Establishes Microbiology KPI Reporting and Metrics.
• Establishes and maintains relevant process controls and data feedback systems to monitor the operation of the department.
• Participates in internal audits, regulatory agencies, and client audits.

Qualifications:

• Bachelor of Science in biological sciences or other relevant field of study.
• 10-12 years relevant microbiology experience in cGMP biotech and/or pharmaceutical environments. Experience in both clinical and commercial manufacturing is preferred.
• Proficient in FDA and EMEA regulations and a working knowledge of root cause analysis.
• Understanding of quality system applications, including the training, deviations, CAPA management, etc.
• Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
• Experience in organizing and leading teams.
• Experience participating in health authority inspections and/or client audits.