Valeant Pharmaceuticals

Senior Clinical Quality Specialist

Job ID
Pos. Category
Pos. Type
Full Time


Support the Clinical Quality Assurance function within Development and Research Operations with primary responsibility for managing non-conformance and change control systems and providing GCP guidance for day to day operations. Secondary responsibilities include supporting GCP training, conducting system, study, site and vendor audits.


• Maintain effective strategies, systems and procedures, ensuring compliance with applicable GCP standards
• Support internal and regulatory inspections.
• Secure and utilize external consultant resources to ensure audits are completed on time and with excellence.
• Support audited groups in developing effective, risk based corrective actions.
• Authors/reviews summary reports, memos and standard operating procedures
• Partner with key customer groups in clinical Operations to develop and meet quality objectives.
• Develop and track key quality performance metrics to identify trends and mitigate emerging quality issues.
• Evaluates and improves existing processes with limited guidance
• Maintains on the job knowledge and skills by participating in applicable training


Key Relationships: Internal and external customers/sites and consultants.


• Minimum BS/BA in related field
• Working knowledge of GCP regulations/ guidelines (ICH, US FDA, ISO)
• Clinical Research Certification strongly desired
• Strong computer skills
• Excellent communication (verbal and written) skills and ability to work effectively on teams..
• Excellent organization skills


Experience may include:

Minimum 5 years’ experience in related healthcare, medical device or pharmaceutical industry


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