Quality Assurance - Senior Executive/Specialist

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Job Description

• Develop and maintain policies, SOPs and Work instructions in compliance with regulatory and industry standards and the company's policies and procedures.
• Responsible for monitoring, investigating and assessing clinical s & pharmacovigilance related processes at global and regional levels for consistency and compliance with applicable laws and regulatory requirements.
• Define quality strategy for existing and new programs. Partner closely with project managers, leaders, and internal and external partners alike to ensure an end-to-end approach for quality management.
• Identify areas of risk (Risk Assessment) in liaison with Operations and develop appropriate audit program
• Own the end-to-end Client Audit/Inspections activities for sites and scope
• Establish quality and compliance activities during transition for new deals.
• Ensure data security/privacy measures are implemented in deal teams, by the delivery leads and deal compliance representatives.
• Implementation and monitoring of Information security and Quality management system controls by utilizing expertise on ISO 9001, 27701, 13485 and 27001 is preferred
• Analysis of RCA&CAPA, monitor effectiveness checks for the same
• Client feedback: collection, collation, analysis and recommendation for improvement on client requirements.
• Support in CSV activities at ClinChoice & in maintenance and improvement of global BCP and DR process.
• Support in organization level data across all the functions globally to develop a dashboard specific to respective department & coordinate with leadership to support in Quality metrics management for projects/deals.
• Work with Global Clients in for Quality Consulting assignments; short/long term.