Clinical Compliance Manager

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Formulate and implement quality and compliance strategies and initiatives throughout the organization.

• Execute intricate internal and external audits and inspections.

• Conduct technical document assessments and other GxP quality tasks that support clinical development programs.

• Manage governance and compliance oversight processes.

• Create and uphold quality guidance, reference materials, and compliance tools.

• Spearhead quality and compliance projects related to clinical processes.

• Offer expertise in GxP regulations.

• Assist in risk evaluation and mitigation efforts.

• Develop, sustain, and enhance documentation for quality management systems, including policies, procedures, guidance documents, and training resources.

• Propel continuous improvement projects for quality systems and operational effectiveness.

• Design and manage tools, dashboards, and reports that track compliance activities and quality metrics.

• Collaborate with various departments to encourage best practices and foster quality partnerships.

• Examine quality concerns and non-conformities, conduct root cause analyses, and apply corrective and preventive measures.

• Lead or assist in internal audits, client audits, regulatory inspections, and investigative site audits.

• Coach and mentor junior auditors and quality professionals.

• Cultivate relationships with internal stakeholders and designated client quality teams.

⛳️ Requirements

• Bachelor’s degree or an equivalent combination of education, training, and relevant experience.

• Over 8 years of experience in clinical quality, regulatory compliance, clinical research, or a related field.

• In-depth knowledge of GxP regulations and the complete clinical trial process.

• Significant experience with Quality Management Systems (QMS), SOPs, and regulatory inspections.

• Exceptional verbal and written communication abilities, including effectively conveying scientific and technical information.

• Proven experience in leading audits and mentoring or training team members.

• Strong analytical, problem-solving, risk assessment, and decision-making skills.

• Outstanding organizational, prioritization, and project management capabilities.

• Ability to establish collaborative relationships and influence stakeholders across various functions.

• Proficient in Microsoft Office and quality management systems, with a quick aptitude for learning new technologies.

• Willingness to travel as business needs dictate.

🏝️ Benefits

• Opportunities for career advancement.

• Professional development through mentorship and coaching.

• Collaboration with skilled colleagues.

• An environment that values innovation, integrity, and ongoing learning.

• Reasonable accommodations for individuals with disabilities.

• Commitment to equal employment opportunities.