Compliance Manager – APAC

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

📋 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 to ensure adherence to quality assurance processes, standards, regulatory guidelines, and client commitments.

• Offer guidance on GxP audit and inspection readiness, preparation, management, and follow-up procedures.

• Act as the primary liaison for client audit and inspection discussions.

• Assist in client audits and GxP regulatory authority inspections, which includes risk assessment, mitigation strategies, staff training, mock interviews, preparation tasks, document review, hosting, facilitation, and follow-up actions.

• Lead, evaluate, and endorse audit and inspection reports.

• Support root-cause analyses and the development of CAPAs; ensure follow-up on implementation, effectiveness checks, and evidence collection.

• Contribute to lessons learned and initiatives aimed at company-wide improvements.

• Create and disseminate compliance guidance, reference materials, repositories, communication channels, policies, procedures, and training for quality management systems.

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

• Develop tools for tracking compliance activities and analyze trends.

• Mentor junior staff and take the lead on group projects.

• Identify and address issues impacting the quality and integrity of clinical research programs.

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

⛳️ Requirements

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

• Over 5 years of quality assurance experience or a comparable mix of education, training, and experience.

• At least 1 year of experience in management or leadership roles is preferred.

• Comprehensive knowledge of GxP, with GCP being a requirement.

• Strong awareness of regional clinical research regulations, requirements, and guidelines, as well as global guidelines/requirements.

• Experience with quality management systems and regulatory frameworks.

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

• Proven track record in root cause analysis.

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

• Detail-oriented with the ability to manage multiple shifting priorities.

• Exceptional verbal, written, and presentation communication skills, including familiarity with medical and scientific terminology.

• Strong negotiation and conflict resolution capabilities.

• Ability to mentor and guide staff while working independently or within a team setting.

• Excellent organizational and time management skills; adaptable with the ability to multitask and prioritize complex workloads.

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

• Experience with Veeva QMS is an advantage.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Reasonable accommodations for individuals with disabilities.

• Commitment to equal employment opportunity.