Director of Clinical Quality

Bausch Health Companies Inc.•Bridgewater, NJ

76d

About The Position

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact. The Head of Clinical Quality is responsible for leading strategies and delivering outcomes of global Clinical Quality. The role provides leadership and direction to ensure that Bausch Health clinical trial conduct and data quality are in compliance with all applicable regulations. The role provides direction to Clinical Quality and Clinical Operations in developing and sustaining a robust quality management system. The role requires adaptability, results orientation, strategic thinking, and teamwork with senior leaders as well as multi-disciplinary internal and external teams. In this role you will provide Quality oversight of Bausch Health clinical trials of pharmaceutical products. Quality oversight of internal Clinical Ops and external investigation sites and suppliers. The role includes at least 3 direct reports with global oversight of Clinical Quality.

Requirements

Ms or Bs in a scientific discipline such as Biology, Pharmacy, Chemistry or Engineering.
A minimum of ten years' experience in clinical development, clinical operations, or managing Good Clinical Practices (GCPs) at a pharmaceutical company.

Nice To Haves

Experience in team leadership, implementation of Quality by Design principles, and a commitment to continuous improvement are strongly preferred.
Key Values: Adaptability, Collaboration, Agility, Strategic Thinking, and Results Orientation.

Responsibilities

Sets and directs effective strategies, systems, and procedures to ensure compliance with applicable Good Clinical Practices (GCP) as they relate to the clinical development and clinical trials for pharmaceutical products. Partner with key customer groups in Clinical Operations to develop and meet business and quality objectives.
Provides Clinical Quality guide and oversight over Bausch Health clinical trials following a risk-based approach and as set by applicable regulations, internal processes or SOPs, and protocols.
Partners with cross-functional senior leaders in the development, review and approval of relevant clinical and product data that supports science driven decisions and risk management principles while remaining agile and a patient centric approach.
Directs an effective and efficient quality risk management process within Clinical Quality. Leads escalation management activities to include risk assessments, driving risk mitigation, and communication to company senior leaders. Directs an effective Corrective Action and Preventive Action (CAPA) program.
Leads continuous improvement of clinical development processes that include Quality by Design and robust knowledge management principles.
Develops and manages audit schedule of internal processes, systems, clinical investigators, and suppliers. Directs a clinical quality audit program that is risk based.
Ensure sponsor and investigator sites inspection readiness. Host internal audits of Clinical Quality and regulatory inspections. Ensure data integrity and compliance with GxPs, ICH, WHO, etc.
Sets goals and objectives for direct reports, focusing on skill and career development as well as business needs. Coach, develop and mentor direct reports.
Secures and utilizes external consultant resources to ensure Clinical Quality activities are completed on time and with excellence.
Plans and manages budget for Clinical Quality activities.
Designs and deploys global Quality strategy and initiatives for Clinical Quality and as part of the R&D Quality Leadership Team.