Manager, Commercial Quality

## Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. 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 **Role and Responsibilities** The Manager, Commercial Quality, is responsible for leading and overseeing across the Ergomed Group Quality operations with responsibility for the management, upkeep and delivery of Quality Cost Grids, Quality as a Service information and supporting Request for Information (RFI) and Bid Defence activities. The Manager, Commercial Quality, works closely with the Associate Director, Client Quality Management to ensure alignment with established frameworks, standards, and expectations. As needed mentors and develops Quality staff within the function to ensure their competence and confidence in developing skills to become subject matter experts. **Leadership and Compliance:** - Lead and guide Commercial Quality activities across the Ergomed group, ensuring compliance with global GxP regulations and standards. - Act as the Subject Matter Expert for GxP Commercial Quality, providing input into Ergomed procedures, policy, and training as required. **Business Development and Client Engagement:** - Act as the central point for commercial quality activities - Drive quality input into client proposals, Requests for Information, presentations, and bid defence activities across the Ergomed group. - Actively participate in the Business Development process as a subject matter expert, providing strategic and tactical input at bid defence meetings. - Interact with Business Development in identifying new business opportunities, developing budgets and proposals, and preparing for and presenting at client meetings and teleconferences. - When required, represent the company by attending client meetings, speaking engagements, and publishing scientific or industry-related articles in industry journals. **Commercial Materials and Quality Management:** - Develop commercial materials to support Quality as a Service activities, maintaining high-quality, consistent deliverables. - Maintain Quality commercial slide decks used to develop collateral for commercial quality needs. - Manage the maintenance of Quality cost grids **Metrics and Reporting:** - Oversee the preparation and analysis of Commercial Quality-related metrics, providing periodic reports to management. **Team Leadership and Development:** - As required, lead, educate, mentor, and develop quality group employees to support Commercial Quality activities, ensuring their competence and confidence in developing skills to become subject matter experts. - Foster a collaborative, high‑performing quality culture across global teams and regions. - Provide coaching and professional development opportunities to enhance staff capability and succession planning. **Client Quality Management:** - May manage project quality and compliance activities, including deviations, CAPAs, training coordination, document management, and support for audit/inspection related activities. ## Qualifications **Educa…