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Senior Compliance Specialist

3 weeks ago

City of Greater Geelong, Australia beBeeQuality Full time $86,500 - $144,000

Job Title: Senior Quality Assurance Professional

About the Role:

The ideal candidate will possess a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.

  • Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit, and site audit) to assess adherence to regulatory standards and company policies.
  • Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance.
  • Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders.
  • Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution.
  • Lead audit facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation.
  • Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement.
  • Oversee and review corrective action/preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues.
  • Perform trend analysis on audit findings, providing data-driven insights to support continuous quality improvement initiatives.
  • Develop and lead auditor training programs by providing guidance on audit techniques, risk assessment, and system approach.
  • Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections.
  • Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment.
  • Stay abreast of evolving regulations and best practices related to clinical research activities to ensure audit strategies remain current and effective.
Requirements:
  • Education: At least an Honor's Bachelor degree.
  • Experience: 7-9 years in quality auditing functions within contract research organizations (CROs), pharmaceutical companies, biotechnology firms, or related organizations.
  • Comprehensive knowledge of compliance and risk management issues relating to clinical research and strong understanding of research ethics and privacy.
  • Prior experience leading a team is required.
Preferred Qualifications:
  • Certified Auditor qualifications (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 technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices, and pharmaceuticals and in the conduct of clinical study operations.
  • Knowledgeable of medical imaging and clinical research industry regulations and standards.
  • Proven ability to work collaboratively within cross-functional global teams.
Interpersonal Skills:
  • Superior written and verbal communication skills required for drafting and authoring documents/reports/presentations.
  • Exceptional interpersonal, verbal, and written communication skills including effective listening, facilitating group discussions, influencing without authority, and providing constructive feedback.
  • Ability to plan, organize, prioritize, and manage workload independently.
  • Capacity to adapt quickly to changing environments, think critically, and learn new tasks applying routine knowledge.
  • Excellent analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming alternatives, and assessing action effectiveness.
  • Proven skill in interpreting, synthesizing, inferring, evaluating, and extracting pertinent data to identify areas of risk, trends, and aggregated issues.