At Compliance Architects®, we take pride in our team of experienced experts. They are dedicated to handling the challenges of Cell and Gene Therapy (CGT). We’re excited to introduce two expert Cell and Gene team members: Diluks De Silva and Teresa Gorecki. With decades of extensive experience and industry insights, Teresa and Diluks are working to ensure our clients meet the highest quality and compliance standards.
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Diluks De Silva: A Leader in Quality and Innovation
With over 20 years in the field, Diluks De Silva brings knowledge in Cell and Gene Therapy, Radiopharmaceutical Therapy, and Biopharmaceuticals. His leadership was vital in establishing the quality manufacturing organization for Novartis’s groundbreaking CAR-T therapy, KYMRIAH, making it successful across the US, EU, and APAC regions. His innovative approach and cross-functional collaboration have been vital in shaping the regulatory landscape for Cell and Gene Therapy commercialization.
In his recent role as the North American Country Quality leader at Novartis’s Advanced Accelerator Applications, Diluks managed quality operations across various sectors, including Radio Pharmacy and supply chain operations. His strategic leadership continues to drive innovation in the field, ensuring that our clients are well-equipped to face the challenges of Cell and Gene Therapy development.
To learn more about Diluks De Silva, click here.
Teresa Gorecki: Expertise Across Multiple Sectors
Teresa Gorecki joins us from Johnson & Johnson, where she served as Vice President of Market Quality. Renowned for her inspection management skills and operational improvements, Teresa has a diverse background involving pharmaceuticals, consumer products, and medical devices. Her experience with biotechnology-derived and cell-based products, including monoclonal antibodies, positions her as a valuable asset in our mission to support Cell and Gene Therapy development.
With over 25 years of experience handling FDA inspections and a deep understanding of Good Practice guidelines (GxPs), Teresa is an expert in navigating the complexities of compliance. Her role at Compliance Architects focuses on ensuring our clients maintain high-quality standards throughout their product lifecycle.
To learn more about Teresa Gorecki, click here.
Our Cell and Gene Services: Navigating Complexity with Expertise
At Compliance Architects, our cell and gene team understands that bringing cell and gene therapies from development to market requires seamless collaboration among manufacturers, supply chain stakeholders, regulators, and policymakers. Our services are designed to facilitate this collaboration and establish robust systems to manage complexity effectively.
Critical Services We Offer:
- Quality Management (QM) Design and Gap Analysis: We develop tailored Quality Management Systems (QMS) for your program and analyze existing frameworks to identify gaps, providing actionable remediation strategies.
- Supplier Oversight: Our team evaluates critical suppliers to ensure their quality standards align with your program’s needs, safeguarding the integrity of your supply chain.
- Audits: We create and execute phase-appropriate audit programs essential for regulatory compliance and developmental success.
- Qualification and Validation: Our experts assist in designing protocols and overseeing studies to ensure robust method qualification and validation.
- Specification Setting: We help identify critical quality attributes (CQAs) and develop specifications using global regulatory insights and statistical tools.
- Remediation Support: We utilize our CRPN Quality Roadmap® methodology to guide you through process and system failures, ensuring effective and resource-efficient solutions.
- Training Support: We promote a culture of compliance through our customizable Writing for Compliance® program, equipping your team with the knowledge they need to adhere to industry standards.
Conclusion
As the Cell and Gene team at Compliance Architects continues to expand, we are committed to providing our clients with unparalleled expertise and support. With Diluks De Silva and Teresa Gorecki’s expertise, we are confident in our ability to help you navigate the regulatory landscape of Cell and Gene Therapy, ensuring your path to the market is compliant but also efficient and effective.
Stay tuned for more insights from our team throughout Cell and Gene month, and feel free to reach out if you need guidance on your Cell and Gene Therapy journey.
Contact Us
To learn more about our cell and gene team at Compliance Architects, contact us by filling out the form below.