QA Compliance Manager – Clinical Trials

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

📋 Description

• Oversee all facets of GxP audits and Regulatory Authority inspections for the organization, investigator sites, and clients.

• Direct and/or assess intricate internal and external audits and inspections.

• Advise project teams and clients on GxP audit and inspection preparedness, management, follow-up, and preparation.

• Act as the main point of contact for discussions regarding client audits and inspections.

• Assist with client audits and GxP regulatory authority inspections, which includes risk assessment, mitigation strategies, staff training, mock interviews, documentation review, hosting, facilitation, and post-inspection follow-up.

• Lead, review, and authorize audit and regulatory inspection reports for clients, internal departments, and GxP.

• Examine root causes of findings and non-conformities and create Corrective and Preventive Actions (CAPAs).

• Monitor the implementation of actions, effectiveness checks, and supporting documentation.

• Contribute to lessons learned and initiatives for company-wide enhancements.

• Develop and disseminate policies, procedures, guidance documents, repositories, communication channels, and training for quality management systems.

• Spearhead process improvement projects and collaborate with cross-functional teams.

• Create compliance-management tracking tools and analyze trends.

• Mentor junior staff and take on project leadership for group initiatives.

• Identify and address issues that impact the quality or integrity of clinical research programs.

• Prepare and deliver audit findings and associated information during departmental, internal operations, and client meetings.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational qualification.

• 5+ years of quality assurance experience, or an equivalent combination of education, training, and experience.

• Preferred 1+ years of management/leadership experience.

• Background in Biology, Pharmacy, or a related field is preferred.

• Comprehensive knowledge of GxP, including essential Good Clinical Practice (GCP) knowledge.

• Strong understanding of regional clinical research regulations, requirements, guidelines, as well as applicable global guidelines/requirements.

• Experience with quality management systems and regulatory frameworks.

• Experience in conducting internal audits and assisting, hosting, or managing client audits and GxP regulatory inspections throughout the region.

• Demonstrated experience in root cause analysis.

• Strong problem-solving, critical thinking, risk assessment, and impact analysis skills.

• Excellent verbal, written, and presentation skills, including proficiency in medical and scientific terminology.

• Strong negotiation and conflict management abilities.

• Capacity to mentor and guide staff while working independently or as part of a team.

• Exceptional organizational and time management skills; adaptability and the ability to manage multiple priorities and complex workloads.

• Advanced proficiency in Microsoft Office Suite and compliance-related software.

• Experience with Veeva QMS is a plus.

🏝️ Benefits

• Access to global team resources to support individual career aspirations.

• Opportunities for collaboration and professional development.

• Mentoring and growth are integral parts of the daily experience.