We are seeking a highly experience and motivated Head of Quality for our Clinical Assay Laboratory. The incumbent will have a strong background in GCLP/GLP, and the development, implementation, and maintenance of a Quality Management Systems (QMS) supporting the testing of preclinical and human clinical samples. The candidate should be knowledgeable in the execution of immunoassays and transitioning pre-clinical assays to compliant clinical testing phase I to III use, applying an incremental, risk-based approach. The incumbent will report directly to the Senior Director Quality at Auro Vaccines and be responsible for all activities relating to the development, implementation, and maintenance of the Clinical Assay Laboratory QMS, and provide quality assurance oversight to laboratory systems and the review and reporting of test results, ensuring that high quality immunoassay test results are reported. The candidate should be knowledgeable in assay development, qualification and validation of clinical assays, and the qualification/validation of equipment and laboratory instruments. and systems to support vaccine trials, including documentation and reviewer strategies. This candidate is required to work in a team environment or independently to meet defined objectives based on an established timeline and deliver project work in a manner that is consistent with the company’s values.
Directly responsible and accountable for all GCLP/GLP Quality oversight activities to preclinical and clinical assay testing.
Develop, implement, and maintain a Quality Management System (QMS) that supports the execution of preclinical and clinical assay testing, in compliance with GCLP and GLP. This includes a high-level quality manual, and a phase appropriate, incremental road map/plan for implementation of GCLP/GLP, followed by quality system SOPs, forms and other documentation reporting mechanisms.
Provide quality oversight to the execution of preclinical and clinical assay testing. This includes, but may not be limited to: review and approval of analytical method SOPS, qualification and validation protocols and reports, as well as analytical instrument and equipment IOQ/PQ and calibration activities; review and approval of laboratory and quality system SOPs; and critical review/audit of immunoassay testing activities.
Manage audits, quality issues, deviations, investigations, and regulatory inspections, as appropriate.
Oversee the Clinical Assay Laboratory Analyst GCLP/GLP training programs. Provide introductory and periodic GCLP/GLP refresher training to Clinical Assay Laboratory personnel.
Assure a phase appropriate/incremental approach to levels of GCLP/GLP compliance, from preclinical testing through to the testing of samples supporting licensed products.
Recruit, on-board, train, and manage subordinate QA personnel reporting into this position; supervise QA Associates providing oversight to the Clinical Assay Laboratory QMS or testing activities.
Ensure that the Clinical Assay group’s activities are performed in compliance with GCLP/GLP and Regulatory agency requirements.
Qualifications - Skills & Requirements
A strong background in GCLP/GMP and the development, implementation, and maintenance of quality systems supporting these regulated activities. Expertise in working within a GCLP/GLP laboratory is required.
Prior training or experience in immunological assays, biostatistics, as it applies to the execution of immunoassays, and critical data review and approval is required.
A working understanding of assay qualification and validation, and the calibration, qualification/validation of laboratory instruments and equipment.
Must have excellent writing and verbal communication skills, and exhibit attention to detail and accuracy.
The ability to work in a cross-functional environment with a can-do, hands on, attitude to drive productivity and efficiency is required. Ability to provide negative feedback to Clinical Assay Laboratory personnel in a positive fashion.
Ability to recruit, on-board, train, and manage subordinate QA personnel reporting into this position; supervise QA Associates providing oversight to the Clinical Assay Laboratory QMS or testing activities.
Able to support Clinical Assay Laboratory Management in troubleshooting technical or regulatory issues or investigations.
Hands on experience with the development, implementation and maintenance of quality systems supporting clinical assay testing in a GCLP/GLP setting.
Experience in immunoassays, analytical method qualification/validation, and laboratory equipment and instrument calibration, qualification, and validation.
Ability to recruit, on-board, train, and manage subordinate QA personnel reporting into this position.
Ability to review/audit/authorize regulated immunoassay testing activities.
A background in immunology, microbiology and/or virology are essential.
Level is flexible based on candidate, education and experience.