Senior Quality Assurance Manager

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.

Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6.

Conducts other ad hoc activities as requested by Director, Quality Assurance and/or VP of Quality.

Specified Additional Responsibilities

Procedural creation, management revision

Training

Analysis and reporting of quality related data.

Effective operational line management of direct reports. Ensures the timely delivery of,

Performance reviews and discussions including annual appraisals

Absence approval management and resource planning

Ensuring adequate cover is in place to meet operational requirements for existing and new contracts

Mentoring and training aligned to development needs and career aspirations of direct reports within the department

Qualifications

• 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-related Quality Management and Assurance

• Sound knowledge of international regulations related to Pharmacovigilance and Medical Information

• Experience of participating in audits and inspections

• Ability to lead, mentor, and develop teams

• Excellent communication and facilitation skills within 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

Additional Information

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

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.