AddressLegend Biotech is seeking anAssociate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based in Raritan, NJ.
Role Overview
The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the Investigations Management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all applicable regulations and organizational performance objectives.
The incumbent will be responsible for providing oversight and co-leadership of the investigation management system, including technical and performance oversight, co-managing investigation teams in a matrix organization, and driving continuous improvement initiatives to enhance investigation quality, timeliness, and productivity.
Key Responsibilities
Co-Lead Deviation Investigations:
- Collaborate closely with the Quality Associate Director to co-lead the deviation Investigations Management system:
- Ensure alignment with GMP regulations and organizational objectives in all investigation activities.
- Standardize and improve the quality of investigations across the organization.
Provide Technical Oversight:
- Offer technical expertise and guidance to investigation teams in root cause analysis methodologies and Corrective and Preventive Action (CAPA) implementation.
- Address recurring deviations and improve investigation quality.
Investigation Team Management:
- Coordinate and lead cross-functional investigation teams.
- Ensure productivity, timeliness, and quality of investigations and CAPA implementation.
- Indirectly oversee Investigations Managers, providing guidance and support.
Risk Assessment and Prioritization:
- Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety, and regulatory compliance.
- Address recurring deviations and health authorities' observations as a priority.
CAPA Management:
- Oversee the timely implementation and effectiveness assessment of corrective and preventive actions identified during investigations.
- Ensure prevention of recurrence and improvement of batch disposition timeliness.
Performance Monitoring, Reporting and Management:
- Monitor KPIs related to investigation quality, timeliness, closure rates, overdue records, and deviations recurrence, and take proactive measures to address gaps and improve overall performance.
- Provide regular reports to senior management and serve as Single Point of Contact (SPOC) for investigation system performance to the Site Leadership Team.
Resource Co-management:
- SPOC and integrator for allocating resources, including personnel, budget, and technology, to support the Investigations Management system, addressing backlog of investigations and improving productivity and timeliness.
Continuous Improvement Initiatives:
- Identify root causes of recurring deviations and delays in investigation closures.
- Lead initiatives to streamline processes, enhance productivity, and improve investigation quality.
Stakeholder Engagement:
- Collaborate with stakeholders across departments to address challenges related to deviation management, investigation quality, and batch disposition timeliness.
- Foster a culture of accountability and continuous improvement.
Training and Development:
- Partner in setting training curriculum for the investigations team.
- Provide training and mentorship to enhance the skills and capabilities of investigation team members in deviation management.
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 15 years of experience, including minimum of 3 years in deviation Investigations Management within a GMP-regulated environment.
- Strong understanding of GMP regulations, root cause analysis methodologies, and CAPA processes.
- Proven leadership and team management skills.
- Excellent communication, collaboration, and stakeholder engagement abilities.
- Demonstrated track record of driving continuous improvement initiatives.
- Training and mentoring experience preferred.
- Must be willing to work onsite. Occasional flexibility based on business needs.
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