Compliance Manager

Medisca•, TX

9d•Remote

About The Position

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.

Requirements

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.
Strong writing skills.
Reliable, accountable, detail-oriented.
Organized, very good judgment and decision making skills.

Nice To Haves

Knowledge of Creatio and MasterControl is an asset.

Responsibilities

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.
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
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
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.