Full Job Description
Description: Legend Biotech is seeking Sr. Manager/Associate Director, GxP Compliance and Auditing as part of Quality team based in Piscataway, NJ.
Company IntroductionFrom the very beginning, we’ve been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients’ bear and the difficulties they face, which drove us to think about what’s next.
We believe it’s time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we're using that hope to ignite the future of CAR-T cell therapy.
Strategic CollaborationLegend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.
Role OverviewThe Sr. Manager / Associate Director GxP Compliance and Auditing will be responsible for the development, implementation, maintenance and continuous improvement of global Compliance programs to support Global GxP operations and compliance at Legend Biotech.
Global Business Process and System owner for Compliance programs
Define and implement compliance processes, procedures, tools and training for Internal and External Auditing, Inspection Readiness, Management Review, Emerging Regulations, Regulatory Trends and Quality Planning.
Identify and implement IT solutions that support Compliance related programs and processes.
Interpret and apply global regulations to processes to ensure compliance.
Work cross functionally in the organization to identify key quality metrics that monitor product quality and drive continuous improvement.
Apply risk-based approach to processes/systems so that areas of higher risk are visible across the organization.
Identify and manage resource needs to support growing organization and operational needs.
Oversee Quality Compliance group responsibilities
Ensure compliance across the organization by sustaining a level of constant inspection readiness to meet regulatory requirements, guidelines and industry standards.
Implement an Inspection Readiness Program that proactively prepares the site for Health Authority inspections (training, pre-audit preparation, tools, hosting, close-out etc.).
Maintain and deploy Inspection Risk Assessment Processes and Scorecards.
Provide PAI/PLI and audit training.
Generate and execute the annual internal and external audit schedules.
Make recommendations to management regarding results of internal and external audits.
Perform vendor risk assessments to determine and evaluate audit frequency.
Conduct GxP quality audits of Legend Suppliers. Prepare and distribute audit reports.
Manage audit CAPAs to ensure that corrective and preventive actions are identified and implemented
Lead the internal audit program to ensure stakeholder system compliance with Legend policies and procedures, and cGxP requirements.
Maintain cGxP related quality system SOPs in compliance with all applicable regulatory requirements to align with existing company policies.
Facilitate and participate in Health Authority Inspections.
Develop and manage the response process for Health Authority and Partner audit observations.
Monitor the regulatory landscape identifying applicable emerging regulations and setting implementation timelines for Legend.
Partner with local operational groups and network sites to foster a proactive approach to compliance.
Provide QA advice to stakeholders (e.g., manufacturing, CROs, CMOs) based on analyses and interpretation of cGxP regulations.
Establish and maintain cGxP compliance audit trends and metrics.
Establish key stakeholder relationships with Global and Site Quality functions, Manufacturing operations and Suppliers. Ability to interact and influence all levels within the organization to achieve compliance.
Relevant college or university degree is required; advanced degree preferred.
Minimum 12 years relevant work experience required; Minimum 5 years of leadership experience including senior level project planning/execution and management of direct reports.
Knowledge of GxP requirements for quality systems/processes that enable compliance;
Ability to provide clear direction and influence individuals across all levels of the organization;
Proven experience in implementing Global processes;
IT system development lifecycle knowledge (requirements gathering, change management, testing, implementation, and continuous improvement etc.);
Experience in defining key quality metrics, metrics reporting, metric analysis and process improvement techniques;
Knowledge of relevant GxP regulations and guidance to include but not limited to 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP Regulations;
Strong written and verbal communication skills;
Proven analytical problem solving and conflict resolution skills;
Flexible, highly motivated, with strong organization skills and the ability to multi task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Ability to work independently and to make decisions based on experience.
Effective interpersonal skills.