Role Summary:
The Senior Quality Compliance Specialist is a strategic and technical expert in quality and compliance, playing a critical role in ensuring adherence to policies, protocols, guidelines, and regulatory requirements. This position requires a deep understanding of regulatory frameworks and risk-based methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.
Audit Planning, Execution, and Management Responsibilities
* Lead comprehensive audits in accordance with regulations and standards governing clinical research, assessing adherence to regulatory standards and company policies.
* Develop strategic audit plans to proactively identify areas of concern and ensure regulatory compliance.
* Provide consultation on GxP requirements and quality assurance strategies, guiding stakeholders.
* Coordinate audit efforts with project management teams, ensuring efficient execution.
* Lead facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation.
* Analyze and interpret audit findings, authoring detailed reports identifying risks, gaps, and areas for improvement.
* Oversee corrective action/preventative action (CAPA) plans, ensuring timely implementation and effectiveness.
* Perform trend analysis on audit findings, providing data-driven insights supporting continuous quality improvement initiatives.
Qualifications:
Requirements:
* At minimum, qualified candidates will have:
Preferred Qualifications:
* Certified Auditor (ASQ, ISO, or equivalent)
* Expertise in regulations and standards governing clinical research, including ICH GCP, ISO 19011, EMA Guideline on Computerized Systems and Data Integrity in Clinical Trials, etc.
* Advanced knowledge of global regulations and industry standards as they apply to clinical research, medical devices, and pharmaceuticals, and in the conduct of clinical study operations
Interpersonal Skills:
* Excellent verbal and written communication skills required to draft and author written documents/reports/presentations
* Strong interpersonal, verbal and written communication skills, including effective listening, facilitating group discussions, influencing without authority, and providing appropriate feedback
* Ability to plan, organize, prioritize, and manage workload independently
* Adaptable to changing environments, able to think quickly, able to deal with ambiguity, and learn new tasks applying routine knowledge