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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) within GMP-regulated environments, with a strong focus on documentation management, training activities, and project coordination. Proven ability to drive quality improvement initiatives and manage cross-functional teams effectively.
Highest-signal resume keywords
Quality Management Systems (QMS)GMP RequirementsCAPA ManagementSOP CreationProject Coordination
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management Systems (QMS)GMP RequirementsCAPA ManagementSOP CreationDocument ManagementKPI MonitoringQuality Improvement Initiatives
Soft Skills
Cross-Functional Team CoordinationChange ManagementTraining Development
Tools & Technologies
Microsoft Office ToolsQuality Management Systems
Industry Keywords
Quality AssuranceLife SciencesPharmacyEngineeringDocumentation Practices
About the role
Key responsibilities & impact- Lead the integration of the Quality Management System (QMS), including documentation and training activities related to the transfer of operations.
- Define and manage documentation scopes associated with transferred activities.
- Support teams in the drafting, review, and continuous improvement of quality documents, including SOPs, procedures, and forms.
- Ensure harmonization of documentation practices across impacted sites.
- Coordinate documentation activities and monitor project timelines to ensure successful delivery.
- Track action plans, identify risks and bottlenecks, and implement mitigation actions to maintain project milestones.
- Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
- Support change management initiatives by facilitating adoption of new processes and addressing resistance to change.
- Coordinate quality events linked to the project, including Change Controls, CAPAs, and deviations.
- Develop and monitor project KPIs and maintain quality trackers to ensure project visibility and compliance.
Requirements
What you’ll need- Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or a related field.
- Strong experience in Quality Management Systems (QMS) within a GMP-regulated environment.
- Strong knowledge of Quality Management Systems, GMP requirements, CAPA management, Change Controls, and deviations.
- Experience in document management, SOP creation, and quality documentation review.
- Proven ability to coordinate cross-functional teams and manage complex projects.
- Good IT affinity, including Microsoft Office tools and quality management systems.
- Experience monitoring KPIs and driving quality improvement initiatives.
- Good level in English.
Benefits
Comp & perks- We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.
- Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects.
- By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.
- Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.