The Associate Director, GVP QA will be a key member of the R&D Quality Team supporting clinical and post-marketing safety as well as oversight of GVP related quality systems and activities. This role will support the development, implementation, and maintenance of a proactive and phase appropriate GVP quality system by fostering a strong Quality Culture, supporting the integration of quality into all aspects of the GVP quality systems and processes, proactively identifying risks and mitigations, and partnering cross-functionally on process improvement activities.

• Act as GVP QA subject matter expert (SME) by providing interpretation of GVP regulations, guidance’s, and procedures. Provide consultation, training, and recommendations to staff to ensure subject/patient safety, data integrity, and regulatory compliance.
• Support the development of the GVP Quality System including, but not limited to, development, review, and approval of SOPs.
• Develop and manage the annual risk based GVP audit schedule for internal systems and processes, vendors, and licensing partners.
• Ensure on-time completion of GVP audits in compliance with the annual audit schedule.
• Manage and oversee audits conducted by contract auditors throughout the planning, conduct, reporting, response, and closure audit phases. Conduct audits as required.
• Assess impact of audit findings and other identified compliance risks to subject/patient safety, data integrity, and business operations and escalate as necessary.
• Review and approve audit reports, audit responses, and ensure corrective actions are completed within required timelines.
• Review key study and regulatory submission documentation, as appropriate.
• Support investigations into significant quality issues, scientific misconduct, and serious breach and coordinate escalation and reporting of potential or confirmed violations to regulatory authorities.
• Facilitate identification of root cause and development of appropriate corrective actions.
• Track corrective and preventive actions and confirm effectiveness, where appropriate.
• Support functional areas and program teams with proactive identification and management of risks.
• Provide support in implementing GLP, GCP, and GVP inspection readiness programs, including mock inspection activities.
• Provide support and act as a GVP QA SME during regulatory inspections.
• Generate, analyze, report, and present metrics to functional teams and Quality management as well as recommend any required actions and monitor implementation.
• Identify and lead/support quality process improvement initiatives.

Job Qualifications:

• Bachelor’s degree in a scientific, healthcare, or related discipline and/or background in medical health profession (RN, Medical Technologist, etc.) required.
• Master’s degree or other advanced degree preferred.

• Minimum of 8 years of experience in the pharmaceutical R&D industry with a minimum of 5 years direct GVP and GCP Quality Assurance experience.
• Knowledgeable of EU GVP modules, ICH GCP regulations and relevant global regulations and guidance for clinical and post-marketing safety.
• Experience technical writing key quality system documents (e.g., SOPs, deviations, CAPA).
• Experience in GVP auditing.
• Excellent communication skills.
• Good decision-making skills
• Strong time management skills with ability to manage multiple projects and timelines.
• Ability to rapidly synthesize complex issues and identify risks in a pragmatic way.
• Motivated individual with a passion for learning in a dynamic, fast-paced environment.
• Experience in working within GCP and GLP regulated environment preferred.
• Experience with Health Authority inspections preferred.
• Some project management experience preferred.