Associate Director Of Client Quality
hace 4 días
Company Description
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient's lives.
The Associate Director of Client Quality, is primarily responsible for ensuring that quality activities conducted for PrimeVigilance's Clients are conducted to a high standard in line with global regulatory requirements, legislation and PrimeVigilance's Quality Management Systems and that the quality cycle is maintained across Client quality activities. You will have responsibility for managing and leading the Client Quality Group
Responsibilities include:
Oversight of Client Quality activities across all clients. Working closely with the Senior Quality Director and the Vice President of Quality to ensure all aspects of PrimeVigilance Quality Management System and the Clients Quality Management System are being adhered to by the Project.
Ensure seamless delivery of all aspects of the Quality Cycle for Clients.
Timely and complete training of the Client Quality Group.
Create and maintain the structure and processes governing the activities of the Client Quality Group.
Oversee all activities of the Client Quality Group, including but not limited to:
Ensure a process is maintained and monitored for review the weekly and monthly regulatory intelligence.
SOPs and Joint Operating Guideline
Support Client Quality Managers with authoring client specific procedures and processes.
Human Resources
Perform routine review of forecasted resources against actual resource for the group.
Ensure that all resources on the project are sufficiently qualified and that all project team members keep their CV, JD and training records up to date.
Systems and Facilities
Maintain oversight and ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for projects and systems as needed and that such plans are tested regularly.
Training
Create and maintain a training matrix is maintain for the Client Quality Group.
Provide training for the Client Quality Group as required.
Maintain oversight of training for Client Quality group.
Quality and Compliance Monitoring
Review and monitor Client Quality Group metrics.
Audits and Inspections
Ensure that the Client Quality Group is audit and inspection ready at all times.
Support Client audits and inspections as required.
Contribute to any risk assessment activities performed by the Quality Assurance team for the Client Quality Group.
Deviation and CAPA Management
Support the Client Quality Group with deviation and CAPA management.
Lead any deviations and CAPAs associated with the Client Quality Group activities.
Qualifications
Life science graduate, pharmacy, nursing or other healthcare related qualification
Strong PV QA experience
Strong organisational skills
Additional Information
Why PrimeVigilance?
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
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