Compliance Manager

Medisca Pharmaceutique Inc; Florida; On-site; USD 100,000 - 170,000; Full time

Benefits offered by this job

PTO and vacation policy

Group Health Benefits

401(k) plan

Job summary

Medisca Pharmaceutique Inc located in Florida seeks a Compliance Manager to lead regulatory and quality compliance initiatives across global jurisdictions. You will drive vendor qualification, risk assessment, and cross-functional oversight to ensure adherence to FDA, Health Canada, EMA, and TGA standards.

The role requires strong regulatory knowledge, project management skills, and the ability to mentor staff while aligning with corporate strategy and quality objectives.

Qualifications

• Bachelor’s degree in science or related field.
• 5–7 years in a managerial role in Quality, Compliance or Regulatory Affairs with ~10 years total experience.
• Knowledge of FDA, Health Canada, EMA, TGA regulations.
• Experience in project management.
• Knowledge of Microsoft Office suite.
• Experience with vendor management is a plus.

Responsibilities

• Plan, manage and execute compliance initiatives across multiple global jurisdictions.
• Communicate risks and mitigation strategies to stakeholders.
• Develop detailed project plans, timelines and resource allocation.
• Lead cross-functional collaboration among QA, Regulatory, Operations, IT and Product Management.
• Lead project meetings, provide status updates and communicate risks.
• Track milestones and deliverables; ensure process alignment with regulatory requirements.
• Develop and deliver regulatory training programs for cross-functional awareness.
• Contribute to corporate compliance strategy and global quality initiatives.

Skills

Regulatory Affairs

Project Management

Vendor Management

Cross-functional Leadership

Quality Assurance

Education

Bachelor’s degree in Science

Tools

MasterControl

Creatio

Microsoft Office

Job description

Job Category: Regulatory Affairs / Compliance

Medisca is a global companyleveragingstrong 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 healthcarewith an unwavering commitment to precision, innovation, and societal impact.

TheCompliance Manageris responsible forleading and overseeing compliance initiativeswhileensuringadherenceof all regulatory requirementsin accordance withlocal 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 thevendorprograms. The ideal candidate will bring strong regulatory knowledge, risk assessment capabilities, and cross-functional collaboration skills to ensure all vendors meet quality,complianceand performance standards.

The opportunity:

Compliance

• Plan,manageand executecompliancedriveninitiatives across multiple globaljurisdictions
• Communicate potential risks and mitigation strategies to stakeholders
• Develop detailed project plans, timelines and resource allocation strategies while ensuring complianceobjectivesare 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 ofVendor Qualification Program

• Design, implement andmaintainthe vendor qualification programin accordance withglobal compliance requirements (FDA, Health Canada,EMAand TGA)
• Lead thequalification and approval process for new vendors, including audits, technical assessments, and quality risk evaluations
• Develop andmaintainvendor 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

• Identifycountry 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
• Mentor and develop staff within compliance functions
• Lead and empowermembers oftheteam;guide them to perform at their best. Set and manage clear targets and KPIs andmonitorprogress.
• Foster ahigh drivenculture 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 EMAregulations.
• Knowledge in project management.
• Knowledge of Microsoft Office suite (Word, Outlook and Excel) required.
• Knowledge of Creatio and MasterControl is an asset.
• Reliable, accountable, detail-oriented.
• Organized, very good judgment and decision making skills.

What’sin 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.