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At KVALITO Consulting, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.
At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results- oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.
If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
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KVALITO Life Science Consultant, CSV & DI Expert
Location: Germany/remote
Mission:
We are seeking a highly skilled CSV Expert with a strong focus on Data Integrity to support a key acquisition project in Israel. This is an exciting opportunity to contribute to a significant initiative within the MedTech sector. The position offers the chance to work collaboratively with global stakeholders and play a critical role in ensuring GXP compliance and robust asset management practices.
Main Accountabilities:
* Conduct detailed GXP assessments for approximately 10 GXP-relevant applications (from a total of 22) to ensure alignment with regulatory standards, particularly in the context of systems inherited from the acquisition.
* Perform CSV assessments to validate systems and ensure adherence to Israel-specific regulatory practices and global standards.
* Provide actionable recommendations on whether to pursue full or partial remediation of systems, ensuring compliance and operational continuity post-acquisition.
* Evaluate asset management tools and workflows inherited through the acquisition to identify improvement opportunities and standardize processes across the organization.
* Collaborate with internal and external stakeholders to implement enhanced asset management practices that align with global compliance standards.
* Work closely with stakeholders across Israel, Belgium, and the United States to facilitate smooth post-acquisition integration.
* Potentially take the lead in managing CSV and data integrity processes or collaborate with designated resource in Belgium for execution.
* Serve as a key liaison, reporting to the project manager based in New Jersey, and ensuring that integration activities align with the organization's strategic objectives.
Key Qualifications:
* Proven experience in Computer System Validation (CSV) and Data Integrity within regulated
* Strong knowledge of GXP compliance requirements and associated best practices.
* Familiarity with Israel-specific regulatory validation practices and expectations, especially in the context of post-acquisition integration.
* Expertise in asset management tools and processes, with the ability to assess and standardize inherited workflows.
* Previous experience working on integration projects following acquisitions is highly desirable.
* Ability to work effectively across multiple time zones
* Excellent leadership and collaboration
* Excellent communication skills in English and German
Key Competencies
* Ability to independently lead CSV and data integrity processes or work collaboratively within a global team.
* Demonstrated capability to assess inherited systems and processes and provide clear recommendations for improvement.
* Strong interpersonal skills to work across diverse regions, time zones, and cultural contexts
* Effective liaison between teams in the acquiring and acquired organizations, ensuring seamless communication and integration.
* Exceptional organizational skills to manage multiple tasks, timelines, and priorities in a complex post-acquisition environment.
* Clear and professional communication to align teams and report project progress to global stakeholders.
* Ability to evaluate complex, inherited systems, identify compliance risks, and implement effective remediation strategies.
We offer great benefits
* Flat hierarchies and responsibility from the beginning
* People-oriented culture
* Diversity and inclusion-focused environment
* Global client projects in a multinational environment
* Flexible working hours and home office
* Involvement in global conferences
* Individual professional development, training, and coaching
* Unlimited full employment contract
* Excellent remuneration package consisting of a competitive salary plus a substantial bonus
If you are a self-motivated and reliable professional who enjoys a hands-on role in business operations, please submit your CV and a cover letter
We look forward to hearing from you!