We are currently seeking an Associate Director of Clinical Quality to work for a global pharmaceutical company based in Morris Plains, NJ. This renowned organization is known for changing lives for the better, and they are looking for a seasoned professional to join a successful and growing team to support their therapeutic areas and clinical development programs. In this role you will represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk.
• Serve as Clinical Quality Business Partner lead for assigned clinical trial programs. Handle multiple projects and ensure overall and timely completion of tasks.
• Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
• Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
• Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
• Leads/Assists in readiness preparation, and/or directly support regulatory agency inspection. Leads/Assist in coordination of response to any findings.
• Lead deviation identification, reporting, and CAPA development.
• Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
• Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
• Fosters a commitment to quality in individuals and a culture of quality within the organization.
• Oversee work of others as needed.
• BA or BS and 10+ years of relevant experience (8+ years of relevant experience with an applicable MS).
• At least 6 years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-pharma sponsor experience preferred.
• Recognized as an expert resource on a range of clinical compliance topics.
• Strong verbal and written communication skills and interpersonal skills.
• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
• Excellent organization skills and project management.
• Able to work equally well as part of a team or independently