Senior Quality Assurance Manager

We are PrimeVigilance (part of reputed company 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 reputed company covering services reputed company: 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 reputed company 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 reputed company a positive impact in patient’s lives.  

Position Summary - Summary of Key Responsibilities

The Senior Quality Assurance Manager ensures reputed company quality improvement through effective management and reputed company 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 reputed company 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 reputed company 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 reputed company the organisation as led by members of the Quality Leadership Team.
• Participates in audits and inspections, including document request provision, reputed company 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 reputed company-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
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with reputed company applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6.

Specified Additional Responsibilities

• Procedural creation, management revision
• Training
• Analysis and reporting of quality reputed company data.

• A university degree in a healthcare discipline or equivalent scientific area

• Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-reputed company Quality Management and Assurance 

• Sound knowledge of international regulations reputed company to Pharmacovigilance and Medical Information 

• Experience of participating in audits and inspections 

• Ability to reputed company, mentor, and reputed company teams 

• Excellent communication and facilitation skills reputed company a global organization 

• Proactive and self-motivated with strong organizational and planning abilities 

• Excellent problem-solving and decision-making skills 

• Attention to detail and commitment to high standards 

• Ability to analyze data and prepare detailed reports 

• Knowledge of quality management principles and practices 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of reputed company 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 reputed company 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 reputed company over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they reputed company with you then PrimeVigilance could be a great company to join!  

• Quality 
• reputed company & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look reputed company to welcoming your application.