Full-Time Director, Quality Management & Compliance

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

• 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

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