Manager, Commercial Quality

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Responsible for leading and overseeing across the Ergomed Group Quality operations. • Manage, upkeep and delivery of Quality Cost Grids, Quality as a Service information, and supporting Request for Information (RFI) and Bid Defence activities. • Work closely with the Associate Director, Client Quality Management to ensure alignment with established frameworks, standards, and expectations. • 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. • Drive quality input into client proposals, Requests for Information, presentations, and bid defence activities across the Ergomed group. • Oversee the preparation and analysis of Commercial Quality-related metrics, providing periodic reports to management. • Provide coaching and professional development opportunities to enhance staff capability and succession planning.

🎯 Requirements

• Degree in Life Sciences, Pharmacy, Nursing, or related healthcare field. • Proven experience in client-facing and stakeholder management roles, with the ability to effectively engage, communicate, and collaborate with internal and external stakeholders. • Experience in preparing presentations, capability decks, and client-facing materials. • Able to demonstrate a sound knowledge of pharmacovigilance and clinical knowledge in order to carry out related duties to a competent level • Experience in preparing and contributing to bids, proposals, and RFP/RFI responses within the Life Sciences and Healthcare domain • Exposure to project management, governance, and operational excellence initiatives. • Experience supporting quality management activities, including deviations, CAPAs, audits, inspections, or process improvement initiatives. • Experience coordinating cross-functional teams in a global or matrix environment. • Proficiency in Microsoft Office Suite (PowerPoint, Excel, Word) and collaboration tools. • English - fluent (spoken, written)

🏖️ Benefits

• 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