Expert consulting for Quality and business process strategy, design, digitization and compliance.
Streamline Your Biopharmaceutical Operations
Expert consulting for Quality and business process strategy, design, digitization and compliance.
About Creative Quality Design
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Purpose
Creative Quality Design enables teams to achieve their mission for the patients, the company and themselves using
creativity and collaboration to improve outcomes.
Consulting Services for Biopharmaceuticals CMC and Quality
Quality Strategy Consulting
Quality Strategy Consulting
Quality Strategy Consulting
Quality Strategy Consulting services help start-ups develop a roadmap for growth and maturity through the product lifecycle. This includes companies transforming due to M&A, changing business landscape or compliance challenges to provide a tailored plan to achieve your business goals.
Digitization Consulting
Quality Strategy Consulting
Quality Strategy Consulting
Digitization Consulting services help design and integrate digital tools across the Quality and business systems including data strategies and migration. Work with your stakeholders, IT and vendors for planning, design, verification / validation and deployment that fits your business needs and helps you achieve your digital goals.
Compliance Consulting
Integrated Business Process Management
Integrated Business Process Management
Compliance Consulting services provide due diligence and audit for vendor network in support of CMC and digital operations. Provide assessment and workplans to remediate compliance concerns across Quality Systems or work with start-ups in anticipation of regulatory inspection for preparation and inspection management.
Integrated Business Process Management
Integrated Business Process Management
Integrated Business Process Management
Integrated Business Process Management services consolidate strategy, technology and compliance opportunities to optimize operations and increase efficiency. Identify areas of improvement, streamline processes, and help you run your business more effectively.
Background & Highlights
Heather Schwalje, Principal and Owner: My Story
My story begins with a passion for making our work easier and building in quality with creative solutions and critical understanding of cross-functional nature of delivering therapies to patients. I believe Quality leaders are uniquely positioned to see across the supply chain to improve outcomes with a "big picture" lens. I have combined this viewpoint with a strong affinity for data and digital process transformations as enabler of high performance. I saw a need for creative, results-driven consulting services for integrated Quality systems and business process management and set out to create a company that would meet that need.
Career Highlights
- Consent decree remediation programs and the application of operational excellence program as basis for workplans with focus in change management
- Facility re-design for retrofit from single product to multi-product Mab platform to meet demands of changing industry
- Transformation of quality operations through start-up and digitization in first of kind paperless plant leading to global consultation with Emerson Process management
- Improved complex ADC external supply chain management and product release
- Transformation of complete QMS with consolidated digitization in AssurX platform
- Develop quality strategies and digital tools for donor-reliant microbiome product using Centraxx, Clinical study software
- Greenfield design, build and start-up for cell and gene therapies
- Strategic redesign of Global Quality operating model in response to changing demand landscape
- Multiple VeevaVault QMS deployments for start-ups through commercial organizations