Director, Inspection Management/Quality Compliance

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    "datePosted": "2024-06-23T08:35:55.782Z",
    "description": "<h2>Overview</h2>\n<p>The Director of Inspection Management/Quality Compliance will report to the VP and Head of Global Quality. The Director, GCP/GVP QA, leads the end-to-end GCP/GVP QA strategy, compliance, and inspection readiness program across the organization. The role oversees a GCP QA team, drives risk-based audits and quality-by-design integration, and manages quality risk processes, metrics, and compliance oversight for GCP and GVP activities. Key compliance responsibilities include monitoring adherence to GCP/GVP regulations, company SOPs, and ICH guidelines; assessing and reporting compliance status across functions; and ensuring timely remediation of findings from audits and inspections. The Director also maintains regulatory intelligence to anticipate changes in global requirements and translates them into actionable QA and compliance standards. Additional responsibilities include leading inspection readiness internally and at clinical sites with CROs, conducting mock inspections and audits with Compliance QA, and acting as the primary moderator for regulatory sponsor inspections. The Director partners with Clinical Development, Operations, Regulatory Affairs, Patient Safety, Data Management, Biostatistics, and external partners to resolve issues and drive continuous improvement. This role aligns QA and compliance strategy with business and regulatory goals, serves as the primary QA point of contact for stakeholders, and ensures clear communication, transparency, and a unified “One Voice for Quality” across the organization.</p>\n<h2>Responsibilities</h2>\n<ul>\n <li>Establishes and maintains the GCP/GVP Inspection Readiness program and supports the development and revision of functional and cross-functional policies and procedures; supports auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines.</li>\n <li>Responsible for the overall health of the GCP/GVP Inspection Readiness program, risks anding with cross-functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks.</li>\n <li>Develops QA GCP/GVP strategy for a team within QA with clear goals and objectives that align with business needs; manages complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives resolution.</li>\n <li>Partners with Compliance Clinical Operations for Clinical Site Audits; uses the outcomes to inform risk-based decisions and development or refinement of metrics designed to identify potential noncompliance at SK-sponsored clinical trial sites.</li>\n <li>Assesses new regulations and guidance to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered.</li>\n <li>Oversees and coaches GCP/GVP QA team members through regular individual touchpoints and team meetings.</li>\n <li>Develops a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability.</li>\n <li>Serves as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance.</li>\n <li>Reviews and approves, as applicable, non-clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable.</li>\n <li>Partners with key stakeholders, including Clinical Operations, Data Management, Safety, other cross functional teams, and QA oversight of the CROs and other critical vendors.</li>\n <li>In partnership with functional stakeholders, identifies and manages issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties.</li>\n <li>Interprets and applies ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol, informed consent, and protection of confidentiality of the test subject, and quality assurance in clinical trial management.</li>\n <li>Provides leadership, compliance, and technical expertise.</li>\n <li>Demonstrates cross-functional leadership, establishes strong relationships, and leverages influencing skills and expertise to drive change and foster a culture of quality.</li>\n <li>Provides guidance, coaching, and development to the QA team.</li>\n</ul>\n<h2>Qualifications</h2>\n<ul>\n <li>Bachelor’s degree in healthcare or a related field (Master’s degree preferred).</li>\n <li>Minimum 15 to 20 Years of solid current pharmaceutical compliance and Inspection Management experience required</li>\n <li>Lead end-to-end GCP/GVP inspection readiness programs, including mock inspections, internal audits, and clinical site audits in partnership with Compliance QA and CROs</li>\n <li>Serves as primary moderator for regulatory health authority sponsor inspections, triaging first-level questions, managing complex requests, and defending company processes and positions to achieve successful outcomes</li>\n <li>Develops and maintains a risk-based QA strategy and quality-by-design framework across GCP and GVP functions, systems, and activities</li>\n <li>Monitors compliance with GCP, GVP, guidelines, and internal SOPs; tracks key metrics to inform risk-based decisions and drive timely remediation of audit findings</li>\n <li>Collaborates with Clinical Development, Clinical Operations, Regulatory Affairs, Patient Safety, Data Management, and Biostatistics to identify, assess, and mitigate patient safety and data integrity risks</li>\n <li>Builds and maintains relationships with functional leaders as the primary QA point of contact, ensuring “One Voice for Quality” in strategic and decision forums</li>\n <li>Delivers training and coaching to cross-functional SMEs on inspection preparation and effective response to regulatory questions</li>\n <li>Manages complex compliance issues with limited data, applying sound judgment to balance business needs, supply, and quality requirements</li>\n <li>Implements process improvements based on peer company best practices and evolving global regulatory expectations to strengthen inspection readiness</li>\n <li>Drives measurable outcomes by aligning QA and compliance initiatives with business goals and regulatory commitments</li>\n</ul>\n<p><strong><u>Compensation & Benefits</u></strong></p>\n<p> </p>\n<p>The anticipated salary range for this position is $180,000 to $220,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.</p>\n<p> </p>\n<p>In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.</p>",
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