Role Overview

We are seeking a seasoned professional to lead software validation efforts for our design and development projects, ensuring top-tier process and product quality within a regulated pharmaceutical environment. This role involves collaborating on the development of a global IT validation strategy, keeping in line with GxP regulations and other relevant compliance standards.

Key Responsibilities

• Spearhead the validation of software for design and development initiatives, ensuring adherence to quality and regulatory standards.
• Contribute to the creation and implementation of a global IT validation strategy, factoring in applicable GxP and regulatory requirements.
• Develop, review, and maintain CSV policies, procedures, plans, and protocols.
• Draft and manage validation documentation throughout the lifecycle, including validation and test plans, risk assessments, and summary reports.
• Conduct reviews to ensure documentation meets regulatory and quality standards.
• Manage validation documentation and lead cross-functional project meetings to align on project goals and execution.
• Assess and review changes to validated systems, ensuring that the validation status is maintained post-implementation.
• Coordinate and lead periodic reviews of validated systems on a global scale.
• Stay updated on regulatory requirements and new techniques, serving as a resource for the team and broader organization, while also providing CSV training.
• Support audits and inspections at company facilities, as well as with subcontractors and service providers.

Requirements

• A degree in IT, engineering, quality, natural sciences, or a related field.
• Proven experience in a similar validation role within the healthcare industry.
• Familiarity with Tracelink and serialization processes.
• Strong understanding of GxP regulations and CSV requirements.
• A successful track record of managing validation projects.
• At least 2 years of industry experience, ideally within IT validation, quality assurance, or product quality in the pharmaceutical sector.
• Knowledge of key quality management and CSV standards such as EU GMP Annex 11, FDA 21 CFR 11, and GAMP 5.
• Experience with medical device regulations (e.g., MDD 93/42 / EEC, MPG, EU-MDR) is a plus.
• Critical and creative thinking skills for managing CSV projects and navigating changing priorities.
• Independent, results-driven communication skills in an international setting.
• Strong problem-solving abilities and excellent computer skills.
• Familiarity with tools like JIRA, ServiceNow, Solution Manager, and TrackWise is an advantage.
• Fluency in English, both written and spoken; knowledge of German is a plus.