55 Cambridge Parkway
Job Category: Clinical: Quality
Job Number: 2035
The Associate Director of Clinical Quality Assurance develops, implements and executes procedures to assure that all clinical activities subject to regulatory review comply with internal standards as well as domestic and international regulatory requirements. This is a leadership position responsible for future development of GCP QA staff and for cross functional collaborations with Clinical Operations and Pharmacovigilance departments. This position identifies and assesses areas of risk; proposes corrective and preventative action (CAPA) plans, assists with development and implementation of solutions.
- Develop risk based audit plan for conducting QA GCP audits of clinical research activities to assess compliance with applicable regulations, GCP and ICH guidelines, sponsor policies and procedures, study protocols and contracts. Organize/coordinate the site and vendor audits conducted by external contract auditors, as appropriate.
- Responsible for conducting audits (both domestic and international) of clinical investigator sites, and vendors, including Clinical Research Organization (CRO), internal product, and system audits. Assess the compliance of internal and external electronic systems used in clinical research.
- Partner with Clinical Operations, Pharmacovigilance, and Regulatory Affairs to ensure compliant GCP implementation.
- Conduct internal audits of clinical study documents such as the Trial Master File, Investigator Brochures, Clinical Protocols, Clinical Study Reports, Case Report Forms, and Informed Consent Forms.
- Review of Standard Operating Procedures to assess consistency and compliance with regulatory requirements and internal standards, and to determine and ensure effective implementation across the organization.
- Work with CROs to create quality agreements, ensure quality standards are met, and resolve issues promptly and effectively.
- Participate in the review of safety and pharmacovigilance practices for clinical compliance.
- Support the administration of the company’ s training program. Conduct GCP training for clinical team members, investigators, clinical site staff, as needed.
- Report significant clinical quality deficiencies to QA management when identified.
- Identify, evaluate, and recommend solutions to problems identified in the performance of QA GCP audits. Prepare clear and concise written reports of audit observations, including an assessment of compliance. Assess adequacy of auditee' s corrective and preventative action (CAPA) plan. Conduct follow up activities as needed to monitor corrective actions.
- Support preparation, coordination, and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections.
- Minimum of a Bachelors’ Degree in a scientific discipline and at least 8+ years prior experience within the clinical, regulatory, or quality environment in the pharmaceutical or biotechnology industry, with 5+ years specific experience in GCP quality assurance auditing and GCP regulations.
- Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements. Complete and thorough understanding of regulatory compliance requirements for US FDA, European Union, and Health Canada.
- Prior experience in conducting compliance audits, development of standard operating procedures, regulatory inspections, and management of quality systems.
- Must be able to execute job duties with significant degree of independence while effectively collaborating with Clinical Operations, Pharmacovigilance, and Regulatory Affairs departments.
- Must be available for approximately 15-20% travel annually, both US and international
- Must have good interpersonal skills and excellent oral and written communication skills.
- Must have knowledge of clinical safety and clinical trial management systems (e.g. Argus, ARISg, Inform, etc.) as well automated quality systems (ex. Documentum, TrackWise, etc.).