Miruna Bala, P.Eng is the Quality Systems group leader and staff scientist 2, at the GSC. Her primary responsibility is to design, implement and monitor Quality Management Systems (QMS) in accordance with applicable regulatory and accreditation standards. She is a qualified Professional Engineer (P.Eng.) and a certified project management professional (PMP). Miruna is a certified College of American Pathologists (CAP) auditor and a British Standards Institution ISO lead auditor. 

Miruna is responsible for bringing key quality programs, Change Control, Audit, Validation, Document Control and Corrective Action/Preventative Action Management programs into compliance with CAP and ISO 27001 standards. She has successfully led the GSC through five CAP accreditation inspections since 2011 and one ISO 27001 certification audit in 2018. Miruna ensures that systems and processes are in place to meet requirements set forth by the ISO 27001 standards.

Miruna also provides quality oversight to the Conconi Family Immunotherapy Laboratory at Deeley Research Centre, BC Cancer. She ensures quality system processes, policies and procedures are developed and implemented in accordance with the Good Manufacturing Practices (GMP) and cell therapy guidelines in order to meet applicable regulations set forth by Health Canada under the Food and Drug Act. She provides quality and regulatory affairs leadership for the development of clinical trial applications and other regulatory documentation for the immunotherapy program, at CFIL.

Miruna authored a paper, “A Quality Management System Application to Investigate and Troubleshoot Process failures: A Case Study of BC Cancer Agency”, in 2010 in the journal of Clinical Governance and presented this paper in The First Annual Quality Congress conference proceedings. Miruna conducts staff education programs in QMS processes and prepares staff for external audits at GSC and CFIL.

Miruna brings 20 years of QMS work experience in the genomic, biotechnology, cell therapy and nutritional supplement industries with extensive knowledge in designing QMS in accordance with CAP, GMP, ISO 9001, ISO 27001 and CLIA standards. She holds a Bachelors of Applied Science Degree in Biological and Process Engineering from the University of British Columbia. Miruna also holds a Master Certificate in Project Management from the Gustavson School of Business, University of Victoria.

Miruna believes in the concept of building quality into processes and products by everyone in the organization to see maximum benefit from the quality program implementation. She is very passionate about ensuring the delivery of high quality data and products consistently to patients and clients in the healthcare industry.


Conconi Family Immunotherapy Laboratory, Deeley Research Centre, BC Cancer
Engineers and Geoscientists of BC

Project Management Institute

BC Cancer Quality Committee


Miruna provides leadership and direction to maintain culture of quality and works collaboratively to set quality framework for the GSC production laboratories and bioinformatics. Formulates, implements, communicates and monitors quality management system processes and policies to meet regulatory requirements, accreditation and certification standards. Provides oversight for the implementation and management of quality activities throughout the GSC including peer reviews, quality initiatives and performance improvements. Provides guidance and mentorship to seven quality professionals at the GSC in quality activities, including but not limited to, internal audit program, corrective and preventive action system, validation program, document control and managing external audits. Responsible for leading the organization through various regulatory, certification and accreditation audits such as CAP, ISO and others as required. Provides continuous support, training, mentoring and development to ensure GSC quality system performs at a maximum performance level. Communicates GSC’s quality framework, policies and procedures to internal staff and external collaborators.    


College of American Pathologists Certification

Coordinated the CAP accreditation project, which was initiated in 2011 for the GSC’s clinical pipeline involving ABI capillary sequencing instruments for testing BRCA1/BRCA2 breast cancer genes. Later in 2013, the clinical pipeline expanded to 16 gene panel testing with Illumina Sequencers, and now the GSC provides targeted capture panel testing for three cancer panels: hereditary cancer panel, onco panel and myeloid panel.

Immunotherphy CAR-T clinical trial

Working with various collaborators from Ottawa Hospital Research Institute and the Biotherapheutics Manufacturing Centre, coordinated activities for preparing the quality overview summary (QOS) of the clinical trial application, addressing all requirements set forth by Health Canada’s guidelines: For Clinical Trial Sponsors- Clinical Trial Applications and guidelines for Preparation of the Quality Information for Drug Submissions in the CTD Format- Biotechnological/ Biological (Biotech) Products.

Information Security Management System (ISMS), ISO 27001 Certification

Coordinated the ISO 27001 certification project by collaboratively working with various internal GSC staff and external certification body to implement ISMS systems, processes and policies in order to meet requirements prescribed under six main clauses and Annex A with 13 control objectives of the standard. The GSC was ISO certified in December 2018 with zero deficiencies. 

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