Compliance Manager

Medisca; Austin (TX); À distance; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

PTO & holidays

Group health plan

401k plan

Career growth opportunities

Employee referral program

Company events

Résumé du poste

Medisca is seeking a Compliance Manager to lead regulatory initiatives across global jurisdictions, including FDA, Health Canada, EMA and TGA. The role focuses on vendor programs, risk assessment, and cross-functional collaboration to ensure quality and compliance in a fast-paced environment.

Ideal candidate has extensive regulatory knowledge, strong project management skills, and the ability to implement strategic regulatory plans globally while mentoring the compliance team.

Qualifications

• Bachelor's degree in a science-related field required.
• Minimum 5–7 years in a managerial role in Quality, Compliance or Regulatory Affairs (total 10+ years).
• Knowledge of FDA, Health Canada, TGA and EMA regulations.
• Experience in project management and cross-functional coordination.
• Proficient in Microsoft Office; Creatio and MasterControl a plus.

Responsabilités

• Lead and oversee global regulatory compliance initiatives.
• Coordinate vendor qualification and qualification audits.
• Develop regulatory strategies for go-to-market in Europe and other regions.
• Design and deliver compliance training to cross-functional teams.
• Collaborate with QA, Supply Chain, Legal and IT to ensure compliant processes.
• Monitor and report on KPIs and risk mitigation plans.
• Maintain licenses and registrations; ensure SOPs align with regulations.

Connaissances

Regulatory leadership

Project management

Cross-functional collaboration

Writing skills

Risk assessment

Formation

Bachelor's degree in a Science related field

Outils

Microsoft Office Suite

Creatio

MasterControl

Description du poste

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.

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:

• CompliancePlan, 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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