Medisca is a global company leveraging strong partnerships to serve healthcare
professionals across diverse wellness disciplines. Offering extensive and
essential solutions - including pharmaceutical ingredients and service, mixing
technology manufacturing, analytical testing, and education – Medisca is
bridging the gaps in healthcare with an unwavering commitment to precision,
innovation, and societal impact.
The Compliance Manager is responsible for leading and overseeing compliance
initiatives while ensuring adherence of all regulatory requirements in
accordance with local and federal laws. This role will focus on planning,
executing, and delivering initiatives that ensure regulatory compliance with
applicable global standards (FDA, Health Canada, TGA and EMA). This role will
also focus on leading the vendor programs. The ideal candidate will bring strong
regulatory knowledge, risk assessment capabilities, and cross-functional
collaboration skills to ensure all vendors meet quality, compliance and
performance standards.
The opportunity:
Compliance
Plan, manage and execute compliance driven initiatives across multiple
global jurisdictions
Communicate potential risks and mitigation strategies to stakeholders
Develop detailed project plans, timelines and resource allocation strategies
while ensuring compliance objectives are met
Act as a liaison between Quality, Regulatory, Operations, IT and Product
Management to ensure seamless execution of cross functional initiatives
Lead project meetings, provide status updates, and communicate risks and
mitigation plans to stakeholders and senior leadership
Track project milestones and deliverables
Collaborate with cross-functional teams to integrate compliance requirements
into business processes
Develop and deliver strategic compliance training programs to ensure
cross-functional awareness and accountability
Serve as a key member of the management team, contributing to corporate
compliance strategy and global quality initiatives.
Oversight of Vendor Qualification Program
Design, implement and maintain the vendor qualification program in accordance
with global compliance requirements (FDA, Health Canada, EMA and TGA)
Lead the qualification and approval process for new vendors, including
audits, technical assessments, and quality risk evaluations
Develop and maintain vendor risk classifications based on criticality and
performance
Work with cross-functional teams (QA, Supply Chain, Procurement, Legal) to
ensure proper vendor onboarding and contract quality agreements
Establish and track vendor performance metrics
Maintain up-to-date knowledge of relevant global regulatory requirements and
industry best practices related to vendor management
Develop and implement regulatory strategy for go to market in Europe
Identify country specific requirements
Conduct regulatory gap assessments of current procedures, for implementation
in European market
Compile European specific documentation
Integrate local requirements within Global processes, where applicable
Conduct compliance risk assessments prior to product or process launches
Maintain licenses and registrations, ensuring SOPs follow applicable
regulations
People Leadership
Mentor and develop staff within compliance functions
Lead and empower members of the team; guide them to perform at their best.
Set and manage clear targets and KPIs and monitor progress.
Foster a high driven culture within your team by empowering them to bring
their best selves to work.
Qualifications:
Bachelor’s degree in a Science related field.
Minimum of five (5) to seven (7) years experience in a managerial role in
Quality, Compliance or Regulatory Affairs, with 10 years total experience.
Knowledge of FDA, Health Canada, TGA and EMA regulations.
Knowledge in project management.
Knowledge of Microsoft Office suite (Word, Outlook and Excel) required.
Knowledge of Creatio and MasterControl is an asset.
Strong writing skills.
Reliable, accountable, detail-oriented.
Organized, very good judgment and decision making skills.
What’s in it for you…
We invest time and resources into making sure Medisca is as good as the people
we hire.
Balance Your Life – PTO, vacation policy and paid statutory holidays
Invest in your health – Group Benefit plan and health savings account
Your Future is Bright – Opportunities to learn and grow within Medisca
Save for your Future – 401k plan retirement
Help us grow – Employee Referral Program
We like to have fun – company events throughout the year
We thank all applicants for their interest; however, only candidates to be
interviewed will be contacted.
We are an equal opportunity employer.
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