Associate Director, Compliance

📋 Description

• • Own and evolve Jadebiosciences’ global GxP audit program—designing, executing, and continuously improving risk-based annual plans that span GLP, GCP, and GMP disciplines across all therapeutic areas and geographies.
• • Lead every stage of the audit lifecycle: from scoping and scheduling through on-site or virtual execution, root-cause analysis, CAPA review, effectiveness checks, and executive-level reporting that drives measurable quality maturity.
• • Build and maintain a living supplier quality risk register that integrates regulatory intelligence, historical performance data, and emerging business priorities to ensure audit resources are deployed where patient safety and data integrity are most at risk.
• • Serve as the primary compliance interface during due-diligence exercises, partnering with Business Development, Clinical Operations, and CMC teams to conduct rapid yet thorough supplier assessments that protect deal value and de-risk post-merger integration.
• • Translate audit findings into strategic insights—delivering quarterly dashboards and board-ready presentations that quantify program performance, trend systemic issues, and spotlight opportunities for proactive quality investment.
• • Mentor and upskill a distributed network of auditors and quality professionals, establishing standardized playbooks, training curricula, and coaching rhythms that elevate audit consistency and foster a culture of continuous improvement.
• • Champion digital innovation by piloting data-analytics tools, remote-audit technologies, and AI-driven risk-scoring models that reduce audit burden while increasing coverage and objectivity.
• • Collaborate cross-functionally with Regulatory Affairs, Pharmacovigilance, Clinical Data Management, and Manufacturing Sciences to ensure audit observations are closed with sustainable, science-based CAPAs that align with global regulatory expectations.
• • Represent Jadebiosciences in health-authority inspections and industry consortia, leveraging external engagement to benchmark our program against best-in-class standards and influence evolving regulatory guidance.
• • Drive supplier performance excellence by instituting a tiered oversight model—combining routine audits, for-cause visits, and real-time KPI monitoring—to ensure CMOs, CROs, central labs, and software vendors consistently meet or exceed contractual quality commitments.
• • Establish and track leading quality indicators (e.g., audit cycle time, CAPA closure rate, repeat-finding frequency) that feed into an enterprise-wide Quality Management Review, enabling data-driven decisions on resource allocation and strategic partnerships.
• • Act as a change agent during post-audit transformation projects, facilitating cross-functional workshops that convert compliance gaps into robust SOPs, enhanced training modules, and risk-mitigation engineering solutions.
• • Ensure audit documentation meets ALCOA+ principles and is inspection-ready at all times, leveraging electronic Quality Management Systems (eQMS) to provide real-time transparency to regulators and senior leadership alike.
• • Foster a psychologically safe audit environment where scientific discourse is encouraged, enabling sites and vendors to openly share challenges and co-create sustainable remediation strategies that strengthen the broader quality ecosystem.
• • Contribute to corporate risk assessments and annual product quality reviews by integrating audit intelligence with post-market surveillance data, thereby shaping long-term compliance strategies and investment roadmaps.
• • Lead or support special projects such as new market entry assessments, technology-transfer quality plans, and crisis-response audits triggered by significant deviations or regulatory actions.
• • Maintain an external network of key opinion leaders, consultants, and regulatory experts to anticipate emerging compliance trends and position Jadebiosciences as a thought leader in next-generation GxP oversight.