Heather Puksta

Portrait of a smiling woman with blonde hair wearing a navy blazer against a black background with purple and green accents.

  • Scientific and technological advancements in the Life Science industry have revolutionized modern medicine and provided – the next challenge is enabling patient access, and I personally am honoured to be a part of delivering revolutionary medicines to patients. I am passionate about making Quality accessible and easy to ensure company-wide adoption and implement a solid Quality culture. I aim to break the stigma of difficult, slow, expensive, and hard to execute Quality programs by ensuring every involved party has a voice in the development of the system. Quality is NOT a one-size-fits-all endeavour, and therefore I find it critical to obtain feedback throughout the process from every level of the organization. I pride myself on delivering fast-track right-sized Quality programs and projects and avoid overbuilding. I take a hands-on approach and enjoy the challenge that each new organization and product brings.

  • With over 12 years’ experience in consulting servicing all aspects of the Life Science industry, I have developed a unique skill set spanning Quality change-management and department leadership to capital project management, to technical Quality system auditing, remediation, and implementation. I am product agnostic and have broad experience working with everything from robotic wheelchairs to CAR-T therapies, to vaccines, to novel diagnostics and everything in between.

    My primary focus has been supporting small to mid-sized organizations through large scale change – whether that be start-up, acquisition, remediation, product launch, or tech transfer. I have a knack for the unique – whether its unique product, unique business set-up, or unique filing requirements, I enjoy diving into a problem to find the right-sized solution for that organization.

    I have implemented many new eQMS/eLMS including Veeva Vault, Qualio, Arena, Agile, TrackWise, EtQ, and ComplianceWire, as well as worked within legacy paper systems and immature electronic record keeping systems.

    • Start-up of cell & gene therapy manufacturing facility, focused on development and implementation of a right-sized Quality system including eQMS and eLMS implementation and migration.

    • Development and Delivery of bootcamp training for Medical Devices, Combination products, and Vaccines.

    • Executive Project Manager for Quality and Validation activities associated with the startup of a novel cell & gene therapy manufacturing facility.

    • Lead Auditor and Program Manager responsible for Quality System Assessments and remediation for a COVID-19 vaccine manufacturing as part of the Operation Warp Speed initiative.

    • Lead Investigator for environmental monitoring excursions associated with mold in a novel vaccine manufacturing facility.

    • Environmental Risk Assessment and control scheme development for a novel 3D organ printing facility.

    • Environmental Performance Qualification development and execution, followed by subsequent Environmental Monitoring program and lab development and implementation for a cell and gene therapy manufacturing facility.

    • Quality System design and eQMS implementation, Manufacturing line commissioning, qualification, and validation for the startup of a Class II Electromechanical Medical Device manufacturer.

    • Facility Design Advisor focused on contamination controls and international regulatory requirements during the design of a Cell and Gene Therapy production facility.

    • Master Project Plan development and subsequent Project Management of Quality and Validation Strategy for medical device manufacturing relocation.

    • Lead Supplier Audits and Remediation of Supplier Qualifications for Orthopedic Surgical Kits.

    • Project Manager responsible for the facility design, clean construction, quality system harmonization, tech transfer. equipment commissioning, qualification and startup of an acquired Medical Device manufacturer into an active Pharmaceutical manufacturing plant during active production. 

    • Lead Investigator on a Root Cause Investigation and Remediation for prolonged poor yield in a bone cement manufacturing facility.

    • Quality Engineer supporting Consent decree remediation of contamination control and sterilization programs supporting a medically necessary multi-SKU medical device facility.

    • Validation Lead for the Commissioning and qualification of a newly constructed API manufacturing suite.

    • Implementation of new QMS elements and systems: I have performed master planning of a QMS, and then systematically implemented QMS elements and SOPs accordingly, providing a focus on building right-sized systems for organizations.

    • Remediation: I have remediated multiple 483 and Consent Decree situations as well as cumbersome costly systems that limit organizational progress.

    • Digitalization: I have migrated multiple paper or simple PDF/electronic signature systems to formal eQMS and eLMS systems. I have also implemented cheap/simple PDF/electronic signature systems when appropriate utilizing a validated DocuSign Part 11 compliant system mixed with access-controlled SharePoint sites.

    • Quality cost reduction: I have performed evaluations of Quality systems to determine if the system is overly cumbersome or costly, and performed cost-reduction of either single elements or systematic wide-scale change.

    • Risk Management: I have developed a variety of risk management tools, but most notably I have developed, implemented, and executed environmental and contamination control risk assessments for a variety of facilities.

    • Supplier Qualification & auditing: I have designed and led the unique task of Supplier Qualification within the Medical Device space as well as performed a variety of Supplier audits for a variety of products.

    • GMP training: I have designed and led both bootcamp level training as a one-off offering, and specific targeted training for newly implemented changes. I have also developed and implemented organization-wide training curricula for individual job roles and implemented eLMS systems for control.

    • Facility Design / Clean Construction protocol: I have been involved in the design and construction of multiple cleanroom facilities, many of which were performing active manufacturing during construction. In these situations, I have developed and implemented clean construction protocols with associated environmental monitoring to ensure control and early-warning of issues during construction.

    • Quality advising: I have worked side-by-side with new Quality leaders to provide individual advisory services as requested.

    • Project Plan Development and delivery: I am adept at developing executable project plans, and delivering on-time and on-budget.

    • Commissioning, Qualification & Validation: I have performed many facility commissioning and equipment qualification activities ranging from simple systems to highly complex automated DeltaV control systems. Additionally, I have led the validation activities associated with manufacturing processes for a variety of products.  I have a unique expertise in validation pertaining to contamination control including environmental performance qualifications, sterilization validations and biological product controls.

CLIENT FEEDBACK

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company