Associate Director/Director, Quality

Company Overview

At Aditum Bio our mission is to provide access to medicines to patients in need.   Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept.   The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

The Associate Director /Director R&D Quality Assurance will oversee the execution of Non-Clinical and Clinical Quality Assurance activities across the Aditum Bio portfolio companies, ensuring activities align with GLP and GCP expectations and the Quality Management System, and works closely with internal and external colleagues to develop systems and processes in-line with regulatory requirements, GCP, GLP, and internal quality processes, as applicable.

This role will also support GxP internal, external, and supplier audits in accordance with international GxP requirements and Aditum Bio standards. The role is responsible for working cross-functionally with stakeholders across the business to support the escalation and management of Deviations, Corrective and Preventive Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

Additionally, the Associate Director/Director will serve as Quality Lead across non-clinical and clinical programs. They will be responsible for providing quality oversight across GLP and clinical activities throughout start-up, maintenance and close out.

The ideal candidate will actively partner with the functions to identify and work on solutions to improve quality. They will leverage his/her experience, understanding of GxP, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

Position Responsibilities

• Lead and provide GLP and GCP Quality Assurance oversight of non-clinical and clinical and activities impacting the Quality Management System.
• Independently lead internal and external audits as defined by the QA Audit Schedule.
• Lead or participate in audits of internal functional areas, investigator sites, and vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Aditum Bio’s Quality standards.
• Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.
• Help prepare internal teams as well as Investigator Sites for Inspection readiness as required.
• Serve as primary non-clinical and clinical Quality representative on internal and external project team meetings.
• Evaluate and provide oversight into potential risks, standards and quality principles.
• Work cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventive Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.
• Maintain an up-to-date knowledge of applicable legislation and regulatory guidelines and provide training to staff on regulatory changes.
• Provide in-depth quality reviews of data and documentation, as required.
• Lead or support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools.
• Provide training/mentoring on clinical QA, GCP and GLP standards and expectations as required.
• Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
• Partner with functions to find solutions for Quality Issues and audit findings.
• Support the development of internal R&D policies and procedures in support of business activities.
• Support the evaluation and implementation of R&D tech solutions in support of trial execution.
• Travel up to 20% for off-site meetings, in-person audits.

 Qualifications

• BS or MS with at least 10 years’ experience within pharmaceutical and/or biotech industry
• Excellent knowledge of GCP and GLP (GVP, CSV and GMP an advantage).
• Knowledge of the industry/clinical trial process and drug development.
• Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.
• Knowledge of corporate governance, health care regulations, laws and standards.
• Strong collaborative, partnering, and interpersonal skills.
• Previous experience working in clinical research, biotechnology or the pharmaceutical industry.
• Excellent analytical, written and oral communications skills.
• Able to foster support and influence all stakeholders throughout the company.
• Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).