Senior Quality Assurance Manager @PrimeVigilance

Company Description

We are PrimeVigilance (part of Ergomed Group), 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.

Job Description

Position Summary - Summary of Key Responsibilities

The Senior Quality Assurance Manager ensures continuous quality improvement through effective management and oversight of Audits and Inspections. Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training. The Senior Quality Assurance Manager leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts. The Senior Quality Assurance Manager ensure that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements.

Roles And Responsibilities

Leads a team which manage audit and inspection findings and observations and their associated corrective and preventative action plans (CAPAs) Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management. Performs periodic trending of Findings across the company, providing insights into the potential causes of trends to operational and quality management.

Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team. Participates in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI

Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings. Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other quality topics Generates metrics on CAPA compliance for Global Quality Council, Quality Leadership, Senior Leadership, and Management review purposes.

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Benefits

• Performance bonus
• Medical subscription
• Extra days off
• Flexible work schedule
• Meal vouchers