Company Description
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We have experienced global organic growth and staff across Europe, North America and Asia covering services in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance supports a wide range of pharmaceutical and biotechnology partners, providing first‑class service across all therapy areas, including medical devices. We invest in staff training and development, prioritise well‑being, and maintain a healthy work‑life balance to deliver high‑quality client service.
Job Description
The Manager, Commercial Quality leads and oversees the Ergomed Group Quality operations, managing Quality Cost Grids, Quality as a Service information, and supporting RFI and bid defence activities.
Role and Responsibilities
- Lead and guide Commercial Quality activities across the Ergomed group, ensuring compliance with global GxP regulations and standards.
- Act as Subject Matter Expert for GxP Commercial Quality, providing input into procedures, policy, and training.
- Serve as the central point for commercial quality activities.
- Drive quality input into client proposals, RFIs, presentations, and bid defence activities.
- Participate in Business Development as a subject‑matter expert, providing strategic and tactical input at bid defence meetings.
- Identify new business opportunities, develop budgets and proposals, and present at client meetings and teleconferences.
- Represent the company at client meetings, speaking engagements, and publish scientific or industry‑related articles.
- Develop commercial materials to support Quality as a Service activities; maintain slide decks and Quality cost grids.
- Oversee preparation and analysis of Commercial Quality–related metrics, providing periodic reports to management.
- Lead, educate, mentor, and develop quality group employees to support Commercial Quality activities, fostering a collaborative, high‑performing culture across global teams.
- Provide coaching and professional development opportunities to enhance staff capability and succession planning.
- May manage project quality and compliance activities, including deviations, CAPAs, training coordination, document management, and support for audit/inspection activities.
- Work closely with the Associate Director, Client Quality Management to ensure alignment with established frameworks, standards, and expectations.
- Mentor and develop Quality staff within the function to ensure their competence and confidence in developing skills to become subject‑matter experts.
Qualifications
- Education: Degree in Life Sciences, Pharmacy, Nursing, or a related healthcare field.
- Required Experience: Proven experience in client‑facing and stakeholder management roles, preparation of presentations and client‑facing materials, and a sound knowledge of pharmacovigilance and clinical duties.
- Desirable Experience: Experience with bids, proposals, RFP/RFI responses, project management, governance, operational excellence initiatives, quality management activities (deviations, CAPAs, audits, inspections), and coordinating cross‑functional teams in a global or matrix environment.
- Special Skills: Proficiency in Microsoft Office Suite (PowerPoint, Excel, Word) and collaboration tools.
- Language: English – fluent (spoken, written).
EEO Statement
We prioritize diversity, equity, and inclusion by creating an equal‑opportunity workplace and a human‑centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
Benefits
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
- Opportunity to work with colleagues worldwide, using English as the company language.
Core Values
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
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