job description
Join Integrity Partners Pte. Ltd. as an Associate Director of Clinical Compliance and Quality and take the lead in shaping Development and Medical Quality Assurance (QA) initiatives across the dynamic Asia-Pacific region. This is a rare opportunity for a strategic leader to drive operational excellence, ensure regulatory compliance, and elevate quality standards in a high-impact healthcare environment.
Based in the vibrant and culturally rich island of Bali, Indonesia, you will collaborate with cross-functional teams to implement best-in-class compliance frameworks, optimize clinical processes, and foster a culture of continuous improvement. Your expertise will be pivotal in aligning business objectives with global regulatory requirements, ensuring seamless operations in a rapidly evolving healthcare landscape.
If you are a visionary leader with a passion for clinical compliance, quality assurance, and strategic development, this role offers the platform to make a lasting impact while enjoying the unparalleled work-life balance of Bali’s tropical paradise.
Responsibility
- Strategic Leadership: Develop and execute comprehensive Clinical Compliance and Quality Assurance (QA) strategies for the Asia-Pacific region, ensuring alignment with global standards and local regulations.
- Regulatory Oversight: Monitor and interpret evolving healthcare regulations (e.g., ICH-GCP, FDA, EMA, local APAC guidelines) to ensure full compliance across clinical operations.
- Process Optimization: Identify gaps in existing QA systems and implement data-driven improvements to enhance efficiency, accuracy, and risk mitigation.
- Cross-Functional Collaboration: Partner with Medical, R&D, and Operations teams to integrate quality principles into product development, clinical trials, and post-market surveillance.
- Audit & Inspection Management: Lead internal/external audits, regulatory inspections, and CAPA (Corrective and Preventive Actions) processes to maintain highest compliance standards.
- Training & Development: Design and deliver compliance training programs for staff, fostering a culture of accountability and continuous learning.
- Stakeholder Engagement: Represent the organization in discussions with regulatory bodies, clients, and senior leadership to advocate for quality and compliance priorities.
- Performance Metrics: Define and track KPIs for compliance and quality, presenting insights to executive stakeholders to drive informed decision-making.
Qualifications
- Education: Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or related field; Master’s or PhD preferred.
- Experience: Minimum 10+ years in Clinical Compliance, Quality Assurance, or Regulatory Affairs, with at least 5 years in a leadership role within the healthcare/pharmaceutical industry.
- Regulatory Knowledge: In-depth understanding of ICH-GCP, FDA 21 CFR, EU GMP, and APAC regulatory frameworks (e.g., PMDA, TGA, NMPA).
- APAC Expertise: Proven experience navigating Asia-Pacific regulatory environments, with a focus on clinical trials, medical devices, or pharmaceuticals.
- Leadership Skills: Strong ability to mentor teams, influence stakeholders, and drive organizational change in a matrixed environment.
- Analytical Mindset: Exceptional problem-solving and critical-thinking skills, with a data-driven approach to compliance and quality.
- Communication: Excellent written and verbal English; ability to articulate complex concepts to diverse audiences, including executives and regulators.
- Certifications: Preferred certifications include RAC (Regulatory Affairs Certification), CQA (Certified Quality Auditor), or PMP.