Results Driven Solutions

Christine Park

For more than 30 years, Christine Park has held key positions that drive cultural change and growth for several large corporations. Her expertise and ability to create lasting change for corporations of all sizes has been recognized throughout her career and her contributions have had a significant impact on the development of sustainable compliance and quality systems, while reducing or managing costs.

While much of her experience has been within regulated industry (medical devices, pharmaceutical, or biologics) she continues to work with companies and organizations of all disciplines and sizes. When you work with Christine Park & Associates, you will receive an accurate assessment of your organization’s current status with a practical, solutions-based plan for the path forward. This ensures your company gets in and stays in compliance with appropriate regulations with sustainable solutions. Working together, we address today’s concerns and build a solid roadmap for the future.

Christine Park is a proven Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. Using a pragmatic approach to compliance and quality assurance, Christine has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations. Her experience in R&D and general manufacturing for medical devices, IVDs, and biotech/pharmaceuticals provides a well-balanced background for her work in compliance.

Whether working on a full quality system or on key quality components (CAPA, complaints, audits, supplier quality, management and document controls), Christine’s holistic approach provides employees and management with clear guidance, direction and tools to maintain compliance with the understanding of why they must comply with specific requirements.

Christine has played an active role in the generation and review of technical documentation in support of regulatory submissions. Her direct experience includes facilitating product and process risk assessments, 510(k) submission, change management (design, as well as manufacturing), product and process validation plans and protocols. She has developed strong relationships with manufacturing and design/development organizations.

Christine received a MBA from Georgia State University through the EMBA program. She has worked with entrepreneurs for many years transferring business practices into actionable real world environments. As a leader within her corporate positions she has developed skills for managing high producing teams that exceed expectations.

Christine is a Certified Master Coach and Master Trainer through Colette Baron Reid’s Invision Lab. She uses many every day tools when working with clients. As a Personal Development coach trained under the renowned Colette Baron-Reid, Christine brings a wide variety of experiences to the coaching arena.

Her tool kit includes:

  • In-Vizion®© visualization process

  • Intuitive Life Strategy Analysis

  • Hypnotherapy

  • Crucial Conversation Strategies

Professional Experience Highlights:

  • Director, Quality Assurance, Cellular Analysis Business Group, Beckman Coulter

  • Director, Quality Assurance, Bioscience, Millipore/Serologicals

  • Director, Quality Assurance, Aksys Ltd

  • Quality Assurance Manager, Quintiles Laboratories

  • Sales/Technical Support/Customer Service Operations, Dupont//Dade Behring

  • Quality Systems/Business Consultant, Christine Park & Associates

Education:

  • MBA, Georgia State University, Atlanta, Georgia

  • BS, Medical Technology, Medical College of Georgia, Augusta, Georgia

Certifications:

  • ASQ CQA (Certified Quality Auditor) – Certificate 27906

  • ASQ CQM/OE (Certified Quality Manager) – Certificate 05419

  • RAPS online regulatory certification for medical devices

  • Certified Hyphotherapist

  • Master Coach and Trainer Invision Lab