Mary Stipancic

Mary Stipancic Email and Phone Number

Executive Advisor ► Lead Start-up Ventures to Operational Excellence, Regulatory Compliance and Strategic Planning for Growth @
Mary Stipancic's Location
Greater Toronto Area, Canada, Canada
Mary Stipancic's Contact Details

Mary Stipancic work email

Mary Stipancic personal email

n/a
About Mary Stipancic

I help Board and C-Level Executives build the infrastructure to realize their vision. How? By driving regulatory compliance and operational efficiency built on pharma best practices and industry requirements. My decades-long executive regulatory compliance and operations experience spans the pharmaceutical, cannabis and psychedelics industries in emerging-growth start-ups and established companies. Achievements include multi-national growth of a best-in-class pharmaceutical CRO specializing in clinical trials, hundreds of successful inspections from global regulatory agencies and pharmaceutical client audits, many industry certifications and licenses including several Health Canada Controlled Drugs and Substances Dealer's Licenses, build-out of a cannabis start-up from the ground up to ready for operations and the transformation of a distressed cannabis company into a Health Canada licensed and NASDAQ listed psychedelics company. Notable appointments include Vice President of Quality Assurance, Senior Quality Assurance Director, and Chief Privacy Officer at Pharma Medica Research Inc., founding member and first employee of HollyWeed North Cannabis Inc. (now Lucy Scientific Discovery Inc. NASDAQ: LSDI) in the role of Chief Compliance Officer, then Chief Operating Officer, Board & C-Level Psychedelics & Cannabis Sector Advisor, past Board Director of two privately-held companies in the cannabis sector.❏ HOW I SUCCEED ❏➥ I’m diplomatic; I treat people at all levels with respect and dignity.➥ I love order and organization, and am all about celebrating success.➥ By being resilient and open to new ideas and ways of achieving results.➥ By seeing the big picture then putting the building blocks and pieces in place to get there.❏ PROMISE OF VALUE ❏➥ I’ll look at things from a regulatory standpoint first to see what basic measures need to be met.➥ I’ll enforce compliance and ensure efficiency, both operationally and fiscally.❏ CAREER SYNOPSIS ❏Executive Advisor – M Advisory Services (2019-present)Board Director – HollyWeed Manufacturing & Extracts Inc. and HollyWeed Grow Inc. (2018-2019)Chief Operating Officer – HollyWeed North Cannabis Inc. (2018 – 2019)Chief Operating Officer – Terracube International Inc. (2018 – 2019)Chief Compliance Officer – HollyWeed North Cannabis Inc. (2017 – 2018)Vice President of Quality Assurance – Pharma Medica Research Inc. (2008 – 2017)Mary Stipancic--------------------Board & C-Level Executive AdvisorContact me on LinkedIn or madvisoryservices@outlook.com

Mary Stipancic's Current Company Details
M Advisory Services

M Advisory Services

Executive Advisor ► Lead Start-up Ventures to Operational Excellence, Regulatory Compliance and Strategic Planning for Growth
Mary Stipancic Work Experience Details
  • M Advisory Services
    Executive Advisor
    M Advisory Services 2019 - Present
    Burlington, Ontario, Canada
    My expertise is in the heavily regulated pharmaceutical (CRO/clinical trials), cannabis and psychedelics industries. I advise start-ups and established company Board and C-Level Executives on regulatory compliance, infrastructure build-out, clinical trials, quality assurance, industry licensing, business growth, and operational excellence. Former Board Director, Chief Operating Officer, and Chief Compliance Officer in the cannabis sector, Chief Privacy Officer and Vice President, Quality Assurance in the pharmaceutical sector and Advisor in the cannabis and psychedelics sectors.❏ LEADERSHIP SCOPE ❏My passion is helping organizations determine where they are and where they want to be, then strategizing and executing the optimal plan to move forward for success and sustainable growth. I can help establish and grow a start-up from the ground up or be the ‘fixer’ of established companies looking to expand to the next level, improve quality, and boost efficiency.❏ NOTABLE ACHIEVEMENTS ❏I grew a multinational pharmaceutical Contract Research Organization specializing in clinical trials, led hundreds of successful regulatory inspections and pharmaceutical client audits, automated and innovated operations, readied a large-scale cannabis processing facility from the ground-up, launched several subsidiaries, obtained many industry certifications and licenses and transitioned the infrastructure and licensing of a struggling cannabis company into a functional NASDAQ listed psychedelics company…all in compliance with stringent regulatory requirements. I am renowned for integrity and respect, empowering others, and making the difficult decisions and actions required to unwaveringly deliver on every commitment. I’ve been where you are now. Please feel free to reach out if I can be of assistance: madvisoryservices@outlook.com.
  • Terracube International Inc.
    Chief Operating Officer → Organized Startup Operations Of Technological Innovation
    Terracube International Inc. Feb 2018 - Oct 2019
    Victoria, British Columbia, Canada
    Built an innovative advanced cannabis grow platform far different than traditional cannabis propagation. Co-developed the technology-driven environment and product design compliant to ISO and GMP standards. Progressed product to R&D phase for full testing in preparation for mass production.❏ LEADERSHIP SCOPE & ACTIONS ❏Led high-level corporate strategic and operational planning, decision and policy making. Determined the quality and compliance directives. Advised on product and service quality and standards.Scaled budget per funding round and development phase. Boosted marketing and sales to expand market reach and sourced vendors.❏ SUMMARY OF KEY MILESTONES ❏➥ Activated start-up to R&D phase; mapped future manufacturing structure for the subsidiary.➥ Influenced a revenue pipeline of high value multimillion-dollar potential international contracts.
  • Hollyweed North Cannabis Inc.
    Chief Operating Officer → Strategic Leadership Of Business Operations + Business Expansion
    Hollyweed North Cannabis Inc. Feb 2018 - Oct 2019
    Victoria, British Columbia, Canada
    Concurrent remote COO leadership of parent company HollyWeed North Cannabis and subsidiary Terracube International. Chose the President for two subsidiaries. Mapped parent expansion to total of 6 brand banners specializing in cannabis research & development, manufacturing, and food production.❏ LEADERSHIP SCOPE & ACTIONS ❏Advanced cannabis facility into operational mode with a pipeline of revenue. Monitored daily operations and adherence to regulatory requirements, business procedures, and process efficiency.Readied as a contract manufacturer for other cannabis entities. Promoted commercial activities for sustainable growth and global marketplace expansion. Board Director of HollyWeed Manufacturing & Extracts Inc. and HollyWeed Grow Inc.❏ SUMMARY OF KEY MILESTONES ❏➥ Signed multimillion-dollar 2-year contract with the world’s #1 cannabis company.➥ Co-designed cannabis extraction area and scaled entire infrastructure for growth.➥ Created expansion strategy built on 5 branded subsidiaries in separate categories.➥ Progressed plan to submission of 3 Health Canada cannabis subsidiary applications.
  • Hollyweed North Cannabis Inc.
    Chief Compliance Officer → Shepherded Licensing + Regulatory Compliance
    Hollyweed North Cannabis Inc. Feb 2017 - May 2018
    Victoria, British Columbia, Canada
    Influenced development from concept to construction, licensing, and operational readiness for pharmaceutical-level manufacturing built on GMP, GCP, and GLP best practices. Installed quality, operational, security, sanitation, and supporting systems required for Health Canada cannabis license.❏ LEADERSHIP SCOPE & ACTIONS ❏Co-managed facility construction and built infrastructure (people, processes, equipment, technology) for plant production and operational efficiency. Organized license application.Regulatory expert on Access to Cannabis for Medical Purpose Regulations (ACMPR), the Cannabis Act, and applicable industry regulations and guidelines.Involved in funding activities, budgets, business plans, brand building, and marketing collateral.❏ SUMMARY OF KEY MILESTONES ❏➥ Granted Health Canada Cannabis Standard Processing License in record time.➥ Instituted infrastructure of quality and operational systems and support functions.➥ Exceeded regulatory requirements via continuous oversight of quality and compliance functions.➥ Set a corporate culture of accountability, collaboration, and continuous improvement.
  • Hollyweed Manufacturing & Extracts Inc.
    Board Member
    Hollyweed Manufacturing & Extracts Inc. Apr 2018 - Sep 2019
    Victoria, British Columbia, Canada
  • Hollyweed Grow Inc.
    Board Member
    Hollyweed Grow Inc. Apr 2018 - Sep 2019
    Victoria, British Columbia, Canada
  • Pharma Medica Research Inc.
    Vice President, Quality Assurance → Orchestrated Business Transformation + Business Expansion
    Pharma Medica Research Inc. 2008 - 2017
    Mississauga, Ontario, Canada
    Activated change management of quality systems and processes at corporate HQ and 2 clinical research sites in Canada and US totalling 800 beds. Executed 2,000+ Phase 1 clinical trials. Boosted brand reputation to Best-in-Class. Expanded client base. Also Chief Privacy Officer (2004 – 2017).❏ LEADERSHIP SCOPE & ACTIONS ❏Deployed Corrective Action Preventative Action (CAPA) process. Enhanced quality system via automation and innovation. Enforced GCP and GLP.Mapped strategy to grow laboratory and clinical research operations. Completed hundreds of regulatory inspections and pharma client audits. Liaised with local and international government agencies.❏ SUMMARY OF KEY MILESTONES ❏➥ Earned reputation as the world’s best Contract Research Organization (CRO).➥ Expanded clinical operations into the US; grew manpower from 60 to 500+ employees.➥ More than doubled efficiency via new in-house developed enterprise-wide software.
  • Pharma Medica Research Inc.
    Chief Privacy Officer
    Pharma Medica Research Inc. 2004 - 2017
    Mississauga, Ontario, Canada
  • Pharma Medica Research Inc.
    Senior Quality Assurance Director
    Pharma Medica Research Inc. 2007 - 2008
    Mississauga, Ontario, Canada
  • Pharma Medica Research Inc.
    Quality Assurance Director
    Pharma Medica Research Inc. 2003 - 2007
    Mississauga, Ontario, Canada
  • Maxxam Analytics
    Regulatory Quality Assurance Manager
    Maxxam Analytics 1998 - 2003
    Mississauga, Ontario, Canada
  • Maxxam Analytics
    Quality Assurance Supervisor
    Maxxam Analytics 1997 - 1998
    Mississauga, Ontario, Canada
  • Maxxam Analytics
    Quality Assurance Auditor
    Maxxam Analytics 1995 - 1997
    Mississauga, Ontario, Canada
  • Maxxam Analytics
    Laboratory Technican
    Maxxam Analytics 1994 - 1995
    Mississauga, Ontario, Canada

Mary Stipancic Skills

Quality Assurance Organizational Development Strategic Planning Change Management Business Intelligence Training Policy Clinical Research Business Process Improvement Regulations Computer System Validation Enterprise Risk Management Executive Management Pharmaceutical Industry Program Implementation Organizational Leadership Glp Gcp Inspection Issue Resolution Client Relations Regulatory Relations Global Regulatory Compliance Privacy Protection Fda Regulatory Affairs Validation Cross Functional Team Leadership Sop Cro 21 Cfr Part 11 Gmp Standard Operating Procedure Good Clinical Practice Cro Management Good Laboratory Practice U.s. Food And Drug Administration

Mary Stipancic Education Details

Frequently Asked Questions about Mary Stipancic

What company does Mary Stipancic work for?

Mary Stipancic works for M Advisory Services

What is Mary Stipancic's role at the current company?

Mary Stipancic's current role is Executive Advisor ► Lead Start-up Ventures to Operational Excellence, Regulatory Compliance and Strategic Planning for Growth.

What is Mary Stipancic's email address?

Mary Stipancic's email address is ma****@****ica.com

What schools did Mary Stipancic attend?

Mary Stipancic attended Laurentian University/université Laurentienne.

What skills is Mary Stipancic known for?

Mary Stipancic has skills like Quality Assurance, Organizational Development, Strategic Planning, Change Management, Business Intelligence, Training, Policy, Clinical Research, Business Process Improvement, Regulations, Computer System Validation, Enterprise Risk Management.

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