Mandy Gibson Email & Phone Number

Saint François Xavier, Mb, Ca

Remote

In collaboration with key stakeholders, I was responsible for the standardization, harmonization and continuous improvement of Clinical Development processes, tools and templates to ensure they were compliant with regulatory requirements, industry best practices, and met business objectives. As a result of my experience and open communication style, my clinical study teams routinely sought me out as a valued compliance resource providing guidance, support and oversight on regulatory interpretation, inspection management and clinical study related issues. In providing this support I was able to help the teams identify potential issues early on, investigate and often mitigate them before they became non-compliances.

In this role I continued to provide guidance on the interpretation and application of regulatory requirements and industry best practices with a focus on Good Clinical Practices (GCP) & Good Laboratory Practices (GLP). As a result, I also supported the continuous improvement of the relevant quality and operational systems to ensure alignment with these regulatory requirements and best practices. I provided Quality oversight for Emergent's Clinical programs from start up through close out, covering all aspects of the study including regulatory inspection support, and site/vendor auditing to ensure compliance. As a senior member of the Quality team I was responsible for mentoring and coaching more junior staff both internal to the Quality team and within my extended clinical study teams.

Winnipeg, Manitoba, Canada

In this role I provided guidance on the interpretation and application of regulatory requirements and industry best practices in various disciplines with a focus on Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) & Good Laboratory Practices (GLP). As a result, I also supported the continuous improvement of the relevant quality and operational systems to ensure alignment with these regulatory requirements and best practices. I provided Quality oversight for Emergent's Clinical programs from start up through close out, including regulatory inspection support, and site/vendor auditing to ensure compliance.

I this role I was responsible for the management of contractual, technical and financial aspects of multiple projects between $500K-$8M+ from initiation through all stages of execution to project close out. This included development of the overall strategic plan, development & management of the program budget, facilitation of decision making, and monitoring of project progress throughout the life cycle, including any mitigations, changes in scope and escalation as required.

Winnipeg, Canada Area

Bachelor Of Science (B.Sc.), Biology, General

Masters Certificate In Project Management