Location: Warsaw, Prague, Barcelona, Stockholm, Copenhagen, Vienna, Budapest or Milan
Employment: Full-time, Permanent
You will be a key member of the Affiliate Quality Operations organization, supporting the effectiveness, compliance, and continuous improvement of CSL's Affiliate Quality Management System across Europe and global affiliates.
In this role, you will partner with Quality leaders, business process owners, and stakeholders across multiple functions to ensure policies, procedures, and quality systems remain compliant, fit for purpose, and aligned with regulatory requirements and CSL standards. You will play a critical role in inspection readiness, quality system governance, process harmonization, and the implementation of global quality initiatives.
This position offers the opportunity to influence quality practices across a complex international environment while collaborating with colleagues from Quality, Regulatory Affairs, Pharmacovigilance, Commercial Operations, Manufacturing, Compliance, and other business functions.
The Role:
Reporting to the Affiliate Quality Head, US & Quality Systems, Standards & Governance, you will:
- Establish and maintain processes for reporting Quality KPIs across global affiliates.
- Coordinate inspection readiness activities throughout the global affiliate network.
- Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.
- Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements.
- Provide quality support to US Commercial Operations as required.
- Support Product Technical Complaint (PTC) activities for the US market.
- Support Global Change Control, Deviation, and CAPA processes across assigned regions.
- Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed.
- Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet.
- Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.
Your Skills and Experience:
- Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field. Candidates with alternative educational backgrounds and significant relevant experience will also be considered.
- Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
- Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.
- Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.
- Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams.
- Strong organizational, communication, influencing, and stakeholder management skills.
- Ability to identify process improvement opportunities and implement practical, innovative solutions.
- Working knowledge of CAPA development and quality system methodologies is preferred.
- Experience supporting or implementing electronic quality systems and digital quality tools is advantageous.
- Strong computer skills, including Microsoft Office applications. Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable.
- Excellent written and verbal communication skills in English.
- Limited travel may be required.
What we offer:
At CSL, we are committed to improving the lives of patients around the world while providing our employees with meaningful opportunities for growth and development. We offer:
