Global Head of Quality Systems (m/f/d)

Global Head of Quality Systems (m/f/d)

• Basel
• Berlin
• Greifswald
• Remote

We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market.

This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE’. In the role as Global Head of Quality Systems, you ensure a robust and compliant Quality Management System that is fully process-based and supported by integrated IT system solutions across all GxP areas (GMP, GVP, GCP). You lead CP quality interfaces, system architecture, and data integrity governance to ensure consistency, compliance, and reliability across the organization.

What makes your day with us special:

Strategic Leadership & Organizational Governance
Lead and develop a global cross-functional organization with full disciplinary and functional responsibility, including resource allocation, budget planning, and acting as the central escalation point (SPOC).

Quality Management System (QMS) Design & Development
Accountable for the design, implementation, and continuous improvement of a robust, process-based Quality Management System across all GxP areas (GMP, GVP, GCP), including core processes such as Deviation, CAPA, Change Control, and Management Review.

System Architecture & Digital Quality Infrastructure
Ensure a compliant and future-ready quality system architecture, including selection, maintenance, and evaluation of eQMS solutions as well as alignment of IT systems supporting the Science Function.

Data Integrity & Computerized Systems Compliance
Accountable for data integrity governance across all systems and documentation, including oversight of computerized system validation (CSV) and compliance with global regulatory requirements.

Quality Governance & Continuous Improvement
Lead quality governance initiatives and QMS improvement programs, ensuring continuous enhancement of system effectiveness in alignment with regulatory expectations and company quality objectives.

Cross-Functional & External Stakeholder Management
Foster cross-functional alignment across departments and serve as primary interface for escalation topics, while engaging with regulatory authorities, CMOs, suppliers, and other external partners on quality system requirements.

Capability Building & Training Excellence
Ensure organizational competency through the design and implementation of training programs and capability development initiatives for internal teams.

What sets you apart:

Academic Qualification & Scientific Background
Master’s degree in a natural science, ideally with a pharmaceutical or GxP-related background, combined with more than 10 years of professional experience in quality management systems.

Leadership & Organizational Experience
More than 10 years of proven disciplinary and functional leadership experience in large, cross-functionally networked organizations within regulated GxP environments (GMP, GVP, GCP).

Quality Systems & Regulatory Expertise
Deep expertise in QMS design, eQMS platforms, data integrity governance, and global regulatory compliance across multiple GxP domains.

Strategic & Analytical Capability
Strong analytical and strategic thinking with the ability to assess systemic quality risks and translate them into structured, actionable improvement initiatives.

Stakeholder & External Interface Management
Experience in collaborating with regulatory authorities and managing external partners such as CMOs and suppliers in the context of quality system oversight.

Digital & System Competence
Familiarity with science IT systems, computerized system validation (CSV), and digital quality management tools in a regulated environment.

What we offer you besides the job:

Corporate culture & internationality
A growing company with a diverse, open working environment and employees from around 40 countries.

Flexible working models & work-life balance
Individually customisable working models, including the option to work from another EU country for up to two months per year. 30 days of holiday.

Individual benefits & pension provision
Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.

Discounts & additional benefits
Access to the corporate benefits platform with discounts at hundreds of partner companies.

Further development & team culture
Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.

We look forward to receiving your detailed application! Please only use the ‘Apply now!’ function to submit your application.

Your contact person:

• Nadine Gustke
• Talent Acquisition Partner
• nadine.gustke@cheplapharm.com

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