Global Quality CSV Specialist (S4 HANA) _ On Contract

Employment Type : On Contract _ till December 2026

Role & responsibilities:

• Lead Global GxP relevant IT Projects.
• Perform Global Quality Approval and Release of GxP relevant IT System Validations
• Manage, create, implement and maintain of harmonized STADA Global GxP Computer Validation System (CSV) Governance.

STADA Global Quality Expert and CSV Champion to provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements.

Lead STADA Global GxP relevant IT Projects

• Lead Quality and other Business Teams in IT System Projects to ensure compliance with Health Authority requirements, such as, GxP and Data Integrity
• Prepare in collaboration with STADA Global IT highest level of Validation Governance documents, such as Validation Plans, in compliance with CSV regulations.
• Lead success closure activities of all required GxP relevant documents that are required for releasing the Global IT system for use/production.
• Present Projects to STADA Global Leadership members, including TechOps and Global IT Senior Vice Presidents and Global Quality Leadership Team.

Global Quality Approvals and Releases

• Approve or ensure compliant approval process of Global GxP Validation key documents, including Validation Plan, URS, Risk Assessments, Testing Plans, Change Controls that are governing the GxP relevant IT System Validations.
• Approve and Release for use/production Global GxP relevant IT Systems, including but not limited to eQMS, EDMS, RIMS, LIMS and SAP.

STADA Global Governance of GxP CSV

• Develop strategies to harmonize STADA Global approach on IT validation for GxP systems to ensure lean, efficient and compliant processes.
• STADA Quality Leader for Global CSV creation, implementation and continuous improvements.
• Identify any gaps of STADA Global CSV against Pharmaceutical Health Authority regulations, including but not limited to EU GMP Annex 11 and Data Integrity.
• Lead required enhancement initiatives to ensure compliance.

STADA Global Quality CSV Expert and Champion

• Global Quality CSV expert during Health Authority Inspection, including all STADA operational sites and commercial affiliates.
• Quality Expert during customer audits at STADA.
• Quality Expert in STADAs audits at IT system service providers.
• Global Quality Expert for STADA GxP IT Validation Project Managers, System Owners, Business Owners, Process Owners and Key Users.
• Global Quality Expert to STADA internal and external clients on any GxP CSV related enhancement initiative and resolution of identified issues, including Data Integrity.
• Provide training to internal STADA customers related to GxP relevant electronic systems.

Preferred candidate profile:

• Minimum 5+ years of experience in Pharmaceutical Quality IT role.
• Strong knowledge on GxP and Pharmaceutical Health Authority requirements on Data Integrity, electronic and automated systems, including EU GMP Annex 11.
• Strong experience in GAMP principals or similar.
• Experience in latest IT developments, including Cloud solutions
• Proven experience in leadership and in execution of GxP relevant IT systems.
• Proven experience in providing training on electronic systems and relevant Quality regulations.
• Experience in Global electronic and automated systems, preferable with SAP, EDMS, LIMS.

Experience with matrix organizations and either in European or global position

• Fluent English
• Ability to work directly with Global Quality Leadership members including Global Senior Vice President, other Global and Cluster Heads, Global Project leads, Subject Matter Experts and project team members.
• Proactive, self-driven, highly motivated, takes responsibility seriously, cooperative, able to work under pressure
• Good communicator, excellent soft skills
• Ability to structure complex facts in an understandable fashion
• Willingness and capability to take decisions
• Technical understanding of electronic and automated systems

Qualification

Graduation / Post Graduation in Pharmacy, Natural sciences, Engineering or equivalent, or long-term experience in the pharmaceutical industry