Head of Quality Strategy for Computerized Systems (all genders) - Inklusiver Job

Merck; Darmstadt; Vor Ort; EUR 100.000 - 130.000; Vollzeit

Zusammenfassung

A leading healthcare company in Darmstadt is seeking a Head of Quality Strategy for Computerized Systems to lead compliance and quality initiatives. This role involves managing QA programs, ensuring regulatory adherence in computerized systems, and executing risk-based validation strategies. The ideal candidate has a strong pharmaceutical background, at least 10 years of QA experience, and leadership skills. Join us to foster a culture of excellence and innovation.

Qualifikationen

• Minimum 10 years in Quality Assurance or computerized system validation in a GxP-regulated environment.
• At least 5 years managing global QA programs for computerized system compliance.
• Proven ability to design and execute risk-based validation strategies for GxP systems.
• Deep knowledge of GLP, GCP, GVP regulations and global health-authority expectations for computerized systems.
• Hands-on experience with system life-cycle management frameworks and change control.

Aufgaben

• Lead the strategic direction for quality management systems for R&D computerized systems.
• Drive continuous improvement initiatives within the QA framework.
• Collaborate with executives to identify risk areas and drive effective issue resolution.
• Manage audits and inspections related to R&D CS and AI technologies.

Kenntnisse

Pharmaceutical industry knowledge

Quality Assurance experience

Risk-based validation strategies

Artificial Intelligence regulatory requirements

Continuous improvement methodologies

Team leadership

Fluency in English

Ausbildung

Advanced degree in Computerized Systems or related field

Tools

eQMS tools

Jobbeschreibung

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role

The purpose of the Head of Quality Strategy for Computerized Systems (CS) role is to lead and establish the strategic direction necessary to ensure the integrity and compliance of quality management systems associated with R&D computerized systems and Artificial Intelligence (AI) technologies. This position is dedicated to driving continuous improvement initiatives within the QA framework, fostering a culture of quality across the organization, and ensuring that all systems adhere to regulatory standards while implementing risk-based validation strategies to maintain the highest quality standards.

This role directs and supports the global Quality Strategy team in executing QA activities related to Computerized Systems (CS) and Artificial Intelligence (AI), including managing audits and inspections for R&D CS and AI technologies. This person is accountable for defining and executing of GLP, GCP and GVP compliant, efficient validation & lifecycle management strategy for global R&D GxP systems & AI; identifying & driving continuous improvement of quality processes for computerized systems based on industry trends, metrics, audit findings, root-cause analyses and stakeholder feedback; continuously assess and refine strategic approaches to drive necessary changes in R&D Computerized Systems and AI, ensuring compliance with regulatory requirements and alignment with industry best practices.

The Head of Quality Strategy for Computerized Systems collaborates with executives and business partners to identify risk areas in Computerized Systems and AI, facilitate prompt communication, and drive effective issue resolution.

Who you are

• Advanced degree (e.g., MSc or PhD) in Computerized Systems, Information Technology, or a related field. A degree in Life Sciences may be considered in combination with an equivalent related professional experience.
• In-depth knowledge of pharmaceutical industry (all GxP areas, with focus on GCP, GVP and GLP) and drug development.
• Minimum 10 years in Quality Assurance or computerized system validation in a GxP-regulated environment
• At least 5 years managing global QA programs for computerized system compliance.
• Deep knowledge of GLP, GCP, GVP regulations and global health-authority expectations for computerized systems
• Proven ability to design and execute risk-based validation strategies for GxP systems.
• Subject Matter Expert and proven working knowledge in, computerized systems validation
• Excellent understanding of Artificial Intelligence regulatory requirements
• In depth knowledge of applicable worldwide CS and AI industry relevant regulations and guidelines
• Hands‑on experience with eQMS tools, system life‑cycle management frameworks, change control and data integrity principles.
• Broad knowledge of continuous improvement, including Root Cause Analysis techniques; Lean Six Sigma knowledge / certification is a plus
• Broad understanding of the drug development process and regulatory environment including specific areas of interest for Merck Healthcare e.g. biotherapeutics, oncology and emerging markets
• Experience in leading a team as a people manager
• Fluency in English (oral and written)

What we offer :

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!