Director, Clinical Quality Assurance

Director, Clinical Quality Assurance (7285)

Career Opportunities: Director, Clinical Quality Assurance (7285)

Requisition ID 7285 - Posted - Central - Quality - US - Remote - City (392)

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. 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 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

Position summary:

This critical leadership position in the Quality organization is responsible for the global implementation and delivery of an efficient, effective and compliant GCP Quality program that meets internal company standards and health authority guidelines and regulations. GCP Quality program supports global clinical program with approximate revenue of $4 Billion with a presence in 20 countries.

This role is a remote role.

Key responsibilities:

• Provides leadership, strategy and compliance oversight of GCP/GLP global program execution, including leading routine governance activities that provide visibility to program effectiveness and compliance.
• Collaborates with Clinical Operations, R&D, Quality Assurance, Pharmacovigilance, Regulatory Affairs in the development of processes, procedures and training programs that improve the efficiency, effectiveness and/or state of compliance of the Clinical Program internally to the company or with external clinical service providers.
• Subject matter expert who provides expertise to project teams and supports programs by conducting compliance reviews of clinical documentation (i.e. clinical study reports, clinical study protocols, investigator brochures)
• Leadership and accountability for the GCP audit strategy and program. This includes the strategy and risk-based approach to clinical study site audits, trial master file audits, qualification audits
• Leads Health Authority inspection readiness preparations that assure successful outcomes
• Develops an engaged and motivated team of Clinical QA professionals

Qualifications/experience:

• BS/BA in science related field; Advanced degree preferred
• Working knowledge and experience of GCP/GLP regulations/ guidelines (ICH, US FDA, ISO)
• Excellent communication (verbal and written) skills and ability to effectively lead teams
• Minimum 15 years of relevant experience in Quality related role in the pharmaceutical industry with at least 5 years of leadership experience.

This position may be available in the following location(s): US - Remote

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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

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