DAVID BLACKETT

CEO and Founder, GxP Quality

ABOUT ME

I’m an accomplished, passionate compliance professional with over 25 years of experience in the life science industry.

I have a proven track record of designing, implementing, overseeing, and auditing quality management systems and compliance initiatives in GxP-regulated environments (GLP, GCP, GMP, and GVP), for Phase I to Fortune 200-sized biotech and pharma companies, and their vendors.


At GxP Quality, my goal is to help biopharmaceutical companies and their service providers ensure consistent quality results of clinical studies, safety programs, and their overall quality management system by providing expertise on realistic, effective quality programs, compliance oversight, and training.

I believe that building strong, collaborative relationships with my clients is essential to delivering effective quality solutions. By taking the time to understand each company’s systems, workflows, and operational context, I am able to design and support quality management strategies that are not only compliant, but also practical and scalable. There is no one-size-fits-all approach in our industry — I tailor my services to fit each client’s specific needs, providing the right level of support at every step, from high-level strategy to the fine details that keep operations running smoothly.

ABOUT MY COMPANY


MY APPROACH

At GxP Quality, I seek to become my clients’ compliance contact of choice for the long term.

I understand that each company’s operations are unique.
I work closely with my clients so I can understand their systems and how they integrate. This allows me to customize my solutions to the company’s specific needs, providing appropriate support where needed – from big picture to the details that matter.


Supported a small biotech through a first-in-human oncology study across multiple countries with full CRO oversight and vendor management.

Conducted global CRO qualification audits including pharmacovigilance, data management, and bioanalytical functions.

Led remediation of data integrity and quality system gaps identified during regulatory inspection.

Designed and implemented right-sized Quality Management Systems for early-stage companies entering clinical development

Performed GxP audits across GCP, GVP, GLP, and CSV domains, delivering clear, inspection-ready findings and recommendations .

Conducted mock inspections to determine sponsor readiness for commercialization.

SELECTED EXPERIENCE


HOW I WORK

Initial discussion
We define scope, key risks, and priorities based on your organization’s stage, structure, and regulatory exposure.

Targeted assessment or audit
I perform a focused review aligned to regulatory expectations, whether for inspection readiness, vendor oversight, or system evaluation.

Clear, inspection-ready output
You receive a structured, practical report with prioritized findings and recommendations that can be used directly for decision-making and regulatory readiness.

Practical support and follow-up
I support remediation activities, CAPA development, and ongoing quality oversight as needed, ensuring improvements are implemented effectively.