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About Mindful Quality

Mindful Quality provides consulting services to a diverse range of life science clients seeking independent professionals to bolster their existing teams on specific projects.  We specialize in assisting our customers in: inspection preparation activities, auditing, cleaning processes and validation, analytical methods, team training, and quality leadership support.  

Our goal is to ensure patient safety, uninterrupted supply of product to market, and corporate integrity.    As a Quality and Compliance consulting firm, we blend our industry expertise with innovation to create custom solutions for our customers in the pharmaceutical, biotech and other regulated process industries.

Mindful Quality can assist in bridging your cGMP compliance gaps. We understand how to navigate the regulatory landscape facing today’s healthcare industry, with deep experience getting new molecules and bio-similars approved, addressing and resolving regulatory issues (e.g. observations, untitled letters, warning letters & complete response letters). 

Our goal is to integrate seamlessly with your team to assure your product gets into the hands of the people who need it most, as soon as possible.

Our Values
  • Patient Safety

  • Regulatory Compliance

  • Uninterrupted supply of product to market

  • Corporate Integrity

How We Help
  • Reduce cost of goods

  • Support approval of product

  • Close cGMP compliance gaps to re-establish Health Agencies' trust 

  • Add new product lines

  • Maintain compliance

  • Optimize cleaning cycles

Our Team

Meet Our Experts

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Jenna, a distinguished Cleaning Validation Subject Matter Expert (SME) with an impressive 25-year career, has held pivotal roles in corporate, site, and external manufacturing capacities across the US, Europe, and Asia.

With a proven track record, Jenna has successfully supported Regulatory Inspections, Observations, Untitled Letters, Complete Response Letters, and Warning Letters. She excels in leading cross-functional teams, strategically achieving critical objectives within tight timelines. Throughout her career, Jenna has demonstrated expertise in developing and remediating cleaning processes, procedures, and validation strategies, consistently identifying time and cost avoidance strategies during program reviews and gap assessments.

In her diverse roles within Validation and Quality Assurance, Jenna has accumulated extensive knowledge of global cGMP requirements and best practices. Her skill set includes authoring Cleaning Assessments, Cleaning Reports, CMC regulatory submissions, and preparing SMEs to speak to inspectors. Notably, Jenna has represented numerous companies during regulatory inspections.

Jenna's contributions extend beyond her professional roles, as she is a recognized industry expert in Cleaning Validation by PDA. She co-authored PDA Technical Reports #29, #49, Cleaning & Cleaning Validation Volume 1, and various articles, solidifying her standing as a thought leader in the field.

President & Chief Consultant

Jenna Carlson

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Tim Cirbo

Principal Cleaning Consultant

A seasoned cleaning expert with 30+ years of manufacturing experience across multiple pharmaceutical facilities in the US, Europe, and Asia, is a distinguished Subject Matter Expert (SME) in the field. His extensive expertise encompasses the design, qualification, and validation of various cleaning systems and facilities.

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Zoe Canfield

Program Manager

Zoe specializes in operational excellence, cGMP best practices, emphasizing process engineering and validation. Zoe diligently oversees all client projects, actively collaborating with client PMO teams, ensuring seamless coordination and driving successful project outcomes.

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Joanna Joseph

Validation Consultant

With expertise in cGMP, biochemistry, organic chemistry, and analytical chemistry, Joanna is a standout contributor. Her proficiency includes regulatory compliance, audits, residue and analysis testing protocol development, SOP optimization, plus the remediation and development of cleaning validation processes.

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Alec Fufidio

Senior Analytical Consultant

Alec's career has been marked by the development and validation of a diverse array of methods for biopharma, providing invaluable insights into the intricacies of analytical method development and validation. His expertise extends beyond the bench, encompassing extensive knowledge of cGMP requirements and best practices.

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Brandi Suhre

Validation Consultant

Over the span of her career, Brandi has immersed herself in hands-on work with mammalian cell culture, bioreactors, and cutting-edge clarification technologies, navigating the complexities of projects from Phase I development through the rigorous FDA approval process.

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Harrison Sweeney

Senior Validation Associate

Harrison has an excellent track record guiding clients through FDA responses, enhancing cleaning programs, and participating in overseas on-site assessments. His commitment to quality blends theory and practice, showcasing a dedication to client success and industry advancement.

How Can We Help?

Tell us what you're looking to achieve.  We'll put our experience to work to solve your specific problem.  If you have any questions or inquiries, please do not hesitate to contact us. Our team is here to assist you and provide you with the information you need.

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