Director, Pharmaceutical Clinical Quality (Remote)

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving peoples lives with our health care products.

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. 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.

Responsibilities

• Secures and utilizes external consultant resources to ensure Clinical Quality activities are completed on time and with excellence.
• 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.
• Designs and deploys global Quality strategy and initiatives for Clinical Quality and as part of the R&D Quality Leadership Team.
• Sets goals and objectives for direct reports, focusing on skill and career development as well as business needs. Coach, develop and mentor direct reports.
• Develops and manages audit schedule of internal processes, systems, clinical investigators, and suppliers. Directs a clinical quality audit program that is risk based.
• 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.
• Leads continuous improvement of clinical development processes that include Quality by Design and robust knowledge management principles.
• 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.
• Plans and manages budget for Clinical Quality activities.
• 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.
• 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.

Qualifications

• Experience of at least 5 years leading or managing GCPs in a pharmaceutical company or 7+ years in clinical development or clinical operations at a pharmaceutical company. Preferable experience in leading a team, the application of Quality by Design principles, and a continuous improvement mindset.
• Key Values: Adaptability, Collaboration, Agility, Strategic Thinking, and Results Orientation.
• Ms or Bs in a scientific discipline such as Biology, Pharmacy, Chemistry or Engineering.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $190k - $220k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

This position may be available in the following location(s): [[location_obj]]

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to [email protected] or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/6d14a0b2d6ae791286e49cc8358d2a3ef29730f9) .

Bausch Health is an EEO/AA employer M/F/D/V.