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.

Key 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.

Qualifications:

• 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.
• 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.

The range of starting base pay for this role is 162K - 223K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.