Director, Quality Management & Compliance - Remote

Overview

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed. 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.

In Short

• Provides leadership and management of the QA team and business partners responsible for overseeing Quality Management System activities
• Provides input into the internal global audit program identifying risks and determining the number and types of audits to be conducted each year.
• Oversees and supports the scheduling, conduct and reporting of audits and reviews of activities in area of expertise, e.g. IT/Technology platforms, computer system validation, (technical) vendors, data management activities.
• Provides oversight of the escalated Issues Management program, including the review, approval, tracking, and closure of escalated Quality Issues (QIs), CAPAs, and Deviations.
• Mentors a team of quality professionals and makes sure that quality deliverables are provided on-time, in compliance with Ergomed standards, regulatory requirements and client expectations.
• Develops and drives continuous process improvements, leading, managing and directing specific assigned projects
• Lead training activities and contribute to policy making decisions as a resource in area of expertise
• Acts as the key contact and leads the preparation and hosting of sponsor audits specific to area of expertise
• Provides guidance and oversight for the analysis of Root Cause and CAPA plans for quality issues (QIs) and audit findings related to relevant area of expertise.
• Provide input and guidance on the interpretation of regulatory requirements, GxP and clinical research related activity guidelines e.g. GAMP5
• Participate in system risk assessments and implementation activities for e.g. IT systems.
• Writes and reviews Quality Assurance departmental controlled documents and reviews other CRO department controlled documents for GCP compliance

Requirements

• Degree qualified in a Life Science related subject
• Demonstrated experience working in a CRO environment with a focus of GCP Quality
• Risk-Based Quality Experience – Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability
• In depth knowledge of the drug development process and worldwide regulatory requirements
• Excellent communication, management and collaboration skills
• Demonstrated ability to lead cross-functional teams
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Effective organizational, presentation, documentation and interpersonal skills
• Effective problem solving and decision making
• Strong customer focus

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