Publicly held medical device company, developing and manufacturing devices and therapies to treat more than 30 chronic diseases. With 86 000 employees at 460 locations in 160 countries. The Montreal-based site, Medtronic CryoCath LP develops and manufactures catheter-based therapy products to treat cardiovascular diseases.As the senior management representative for MMO’s Quality System, responsible for developing and implementing a best-practices approach to quality systems, creating a… Show more Publicly held medical device company, developing and manufacturing devices and therapies to treat more than 30 chronic diseases. With 86 000 employees at 460 locations in 160 countries. The Montreal-based site, Medtronic CryoCath LP develops and manufactures catheter-based therapy products to treat cardiovascular diseases.As the senior management representative for MMO’s Quality System, responsible for developing and implementing a best-practices approach to quality systems, creating a sustainable culture of quality across the site.Manage MMO’s relationships with Notified Bodies and other external / internal quality and regulatory groups and agencies ensuring a common vision and best practices approach to compliance during audits on-site.Responsible for QA oversight of all medical device manufacturing activities in Montreal production areas. Establish a culture of accountability, transparency and collaboration in support of business objectives, ensuring that the quality organization is able to measure the performance of the organization and identify potential issues that could unfavorably impact site objectives. Show less

Ensure finished device quality by maintaining efficient and compliant quality control activities from incoming component receipt to final product release.Partner with manufacturing in order to drive continuous improvement initiatives, supporting growth at the site while complying with all quality system requirements.Provide leadership and strategic direction, drawing upon my deep and broad regulated industry experiences to create a world-class quality culture throughout MMO… Show more Ensure finished device quality by maintaining efficient and compliant quality control activities from incoming component receipt to final product release.Partner with manufacturing in order to drive continuous improvement initiatives, supporting growth at the site while complying with all quality system requirements.Provide leadership and strategic direction, drawing upon my deep and broad regulated industry experiences to create a world-class quality culture throughout MMO, helping to grow MMO’s business in the last 7 years while minimizing quality issues;o 25%-35% YoY growth from 2012 to 2019o from 125 employees to the current 700Built and developed MMO’s quality manufacturing team into a cohesive, credible organization recognized for their expertise and thought leadership, allowing the business to grow to where it is today. Show less

Privately held biopharmaceutical company operating in the field of endocrine disorders, women's health and hormone-sensitive cancer prevention and treatment. 500 employees at 3 sites in Canada. Director, Quality Assurance (2010-2012)Was responsible for QA oversight of entire clinical (GCP), analytical / bioanalytical (GLP) and manufacturing (GMP) operations. Led the auditing of bioanalytical studies, clinical sites, information systems and suppliers to ensure compliance… Show more Privately held biopharmaceutical company operating in the field of endocrine disorders, women's health and hormone-sensitive cancer prevention and treatment. 500 employees at 3 sites in Canada. Director, Quality Assurance (2010-2012)Was responsible for QA oversight of entire clinical (GCP), analytical / bioanalytical (GLP) and manufacturing (GMP) operations. Led the auditing of bioanalytical studies, clinical sites, information systems and suppliers to ensure compliance with regulatory agencies, GxP and internal procedures and protocols. Coordinated, planned and hosted regulatory inspection activities at Endoceutics in Canada and abroad.Was responsible for the entire quality system, ensuring compliance to all external regulatory requirements (GxP, IND, NDA) and quality requirements internally.Was responsible for QA oversight of the computer systems validation (CSV), OOS, Deviation, CAPA programs. Additionally responsible for release of all raw materials (API) and finished products.Oversaw the review and approvals of all quality system documentation within the document management system (SOLABS).Developed, supported, and led budgeting process for the Quality organization, ensuring appropriate level and use of resources to meet objectives. Was a key contributor in providing quality oversight of Endoceutic’s (Phase II and II) clinical and manufacturing which paved the way for eventual FDA approval of INTRAROSA, the company’s breakthrough product, indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Show less

Privately held biotech company pioneering the discovery of genes, biomarkers, and biochemical pathways that are involved in disease susceptibility and drug response using genome-wide association studies. The company’s IP consists of clinical recruiting and results in 36 therapeutic categories. 150 employees at 4 sites in Canada. Independent Consultant for Genizon BioSciences (2010-2011)QA Manager (2008-2010)Computer Systems Validation Manager… Show more Privately held biotech company pioneering the discovery of genes, biomarkers, and biochemical pathways that are involved in disease susceptibility and drug response using genome-wide association studies. The company’s IP consists of clinical recruiting and results in 36 therapeutic categories. 150 employees at 4 sites in Canada. Independent Consultant for Genizon BioSciences (2010-2011)QA Manager (2008-2010)Computer Systems Validation Manager (2004-2008) Show less

Publicly held biopharmaceutical company (Eventually became Syneos Health) providing global contract research services from drug discovery / pre-clinical through all phases of drug development and manufacturing. IT Project Manager (2002 – 2004)Senior Business Analyst (2000 – 2002)

Publicly held multi-service contract research organization providing bioanalytical research, regulatory support, clinical studies and animal metabolism studies to Canadian, American and European pharmaceutical and biotechnology companies. LIMS Implementation Manager (1998-1999)Lead Scientist – LCMS (1995-1998)Operator / Analyst – GCMS Engine (1994-1995)Analyst – GC / GCMS (1993-1994)Clinical Research Technician (1992-1993)