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Position Summary
The Lead of Clinical Compliance will provide effective leadership, and direction to internal and external resources to implement best clinical practices and ICH/GCP guidance within Clinical Operations. The role involves the management and maintenance of clinical quality management systems associated with standard operating procedures, CAPAs management, process improvement, training, and risk management. This key role will also lead ongoing inspection readiness by supporting the development and review of inspection readiness tools and participating in regulatory inspection preparation activities. Reporting to the Head of Clinical Compliance you will support Clinical Operations in collaborating with Quality Assurance to implement process improvement strategies.
Responsibilities
Requirements
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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
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