Reporting to the Head of Quality Systems and Regulatory Affairs, the Quality System (QS) Manager is responsible for the management and operation of the Quality Management System (QMS) of the Conconi Family Immunotherapy Laboratory (CFIL) at the Deeley Research Centre in Victoria, BC. The QS Manager will provide oversight and management of quality activities related to clinical trial execution and GMP driven cell-based manufacturing of clinical drug development. The QS manager will also support the design and development of Quality Control tests, procedures and specifications for preclinical and clinical trial programs. The QS Manager will be accountable for assuring compliance with applicable regulatory requirements and internal QMS requirements, identifying/driving quality system improvement and generation of metrics to drive continuous improvement.
LOCATION AND TRAVEL
This position is primarily located in Victoria, BC, and occasional travel to Vancouver will be required.
- Responsible for the management, maintenance and monitoring of the existing QMS for the CFIL’s Cancer Immunotherapy Program to assure compliance with GCP, GMP, Health Canada and other applicable regulatory requirements.
- Develops and implements quality policies and procedures while ensuring they are carried out under controlled conditions.
- Maintains a comprehensive change control and validation program for changes in pipelines, processes, equipment, reagents and consumables.
- Supports the internal and supplier audit programs, conducts supplier audits and generates audit reports as needed.
- Participates in supplier evaluation and qualification while being responsible for customer/supplier agreement development and/or annual review.
- Attends to day-to-day quality issues and alerts appropriate personnel of recurring problems and/or quality deficiencies.
- Participates in the external accreditation (e.g. FACT) and client assessments. Interacts with the auditors addressing questions.
- Drives investigations to closure, facilitating root cause analysis and the development of effective CAPA plans.
- Supports and provides oversight for the maintenance of the quality control program to ensure conformity of raw material, purchased reagents and material and final products to quality standards.
- Establishes user requirements for purchase, qualification of QC analytical equipment. Works with internal and external resources to maintain equipment in an optimal state.
- Supports and oversees the development and management of QC release assays, documentation for in-process and final product release and stability testing programs.
- Responsible for analyzing and trending QC data, generating stability and other trending reports as necessary.
- Serves as a subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
- Participates and authors analytical sections of regulatory submissions as needed
- Leads analytical method validation and reviews technology transfer protocols.
- Maintains, monitors and implements additional environmental and personnel monitoring programs to ensure compliance to regulatory requirements for a multi-product manufacturing facility.
- Oversees the management of the current document control system ensuring only current and valid documents are used.
- Accountable for the preparation of the annual QMS review reports and for ensuring that the performance of the QMS is periodically reviewed by senior management for effectiveness and continuing suitability.
- Identifies training requirements and provides educational sessions on quality policies, processes and procedures to CFIL staff.
- Develops positive relationships with various stakeholders including internal and external scientific and clinical collaborators.
- Recruits, trains and manages QS staff as needed. Performs ongoing competency assessment and performance evaluations, sets goals and provides feedback.
The ideal candidate will possess the following qualifications in terms of education, work experience and competencies.
- A level of education, training, and experience equivalent to PhD in a science related filed, preferably in cell biology, immunology, molecular biology or biochemistry with 3+ years of QC/QA experience or MSc with 6+ years or BSc with 8+ years of QC/QA experience in the GMP regulated biopharmaceutical or pharmaceutical industry supporting gene/cell therapy product manufacturing for clinical and/or commercial use.
Professional Work Experience
- Advanced working knowledge and understanding of Canadian and international (e.g. ICH) GMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/drugs produced for clinical trial investigation.
- Minimum of 2 years demonstrated track record of management of QA/QC groups with people development and performance management skills.
- Demonstrable working knowledge in managing and monitoring of QMS.
- Expert knowledge of Health Canada, FDA and ICH regulatory requirements for cell therapy products.
- Experience in performing internal and supplier audits.
- Experience in deviation investigations, determining root cause, and developing corrective action plans.
- Experience in process justification, process validation, risk assessment, training and document management.
- Demonstrable experience of QC analytical methods and in-depth knowledge of US and European Pharmacopeia requirements for biologic product testing and method validation.
- Sound understanding and demonstrated application of statistical methods/tools.
- Identifying, writing, evaluating and closing OOS’s and investigations.
- Experience with the application and validation of analytical techniques in a QC environment, including Compendial testing, Spectrometry, Chromatography, ELISA, PCR, Cell-based potency assays.
- Direct experience with batch review and release of cell therapy product lots is considered a plus.
- Skilled use of Word, Excel and other similar programs along with experience with an electronic Quality Management System or Laboratory management System is an asset.
- The CFIL facility is embedded in a research institution; therefore experience working at the interface between a research environment and a regulated environment would be an asset.
- Excellent analytical and project management skills
- Effective written and verbal communication skills
- Exceptional critical thinking, troubleshooting and problem solving skills
- Strong organizational skills and ability to manage multiple priorities
- Self-motivated, detail-oriented and comfortable in a fast-paced research environment with minimal direction and able to adjust workload based upon changing priorities
Canadian citizens and permanent residents will be given priority.