Shaun Hastings
Director of Quality Assurance @PHARMExcel
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WORK HISTORY
Director of Quality Assurance @PHARMExcel
Welwyn Garden City, GB
Responsibilities include: Develop and implement a global clinical quality assurance strategy aligned with organisational objectives and regulatory requirements. Provide leadership and oversight for the clinical quality assurance team, fostering a culture of excellence and continuous improvement. Conduct risk assessments to identify and mitigate potential risks to the quality of clinical trial data and participant safety. Collaborate with cross-functional teams, including clinical operations, to ensure a coordinated approach to quality management. Lead and conduct internal GCP audits and assessments to evaluate compliance with Good Clinical Practice (GCP), standard operating procedures (SOPs), and regulatory requirements. Oversee the auditing of external vendors, including contract research organisations (CROs), and clinical trial sites to ensure adherence to quality standards. Stay abreast of changes in International regulatory requirements and industry standards and ensure ongoing compliance in clinical trial conduct. Drive the development, review, and update of SOPs related to clinical quality management. Lead investigations into quality issues, deviations, and non-compliance incidents, and implement corrective and preventive actions. Ensure the clinical operations teams are prepared for regulatory inspections by health authorities and coordinate responses to inspection findings. Ensure company complies with ISO 9001:2015 certification requirements and maintains a compliant QMS. Sit as a member of the Executive Leadership Team (ELT) and contribute to the overall business strategy, development and growth initiatives.
EDUCATION
Cranfield University
Master of Science (MSc), Quality Management in Scientific Research and Development
SKILLS
ABOUT SHAUN HASTINGS
Clinical research only works when quality is treated as a culture - not a checkbox. That belief has shaped my entire career.I’ve spent over two decades strengthening the integrity of clinical trials across pharma, CROs, and investigator locations.My work centres on one mission: to elevate the standards, behaviours, systems and people that protect patients, data, and scientific credibility.I specialise in- GCP, quality assurance & compliance - Audit strategy & inspection readiness - Quality culture and operational excellence - Service Provider oversight & risk‑based quality management - SOP governance & continuous improvement Across my roles, I’ve supported complex studies, led audit programmes, prepared teams for and hosted regulatory inspections, and helped organisations embed quality into everyday decision-making.I’m also an active contributor to the QA community where I help shape conversations about the future of quality.What drives me is simple: Clinical research deserves better - better systems, better behaviours, better outcomes. And I believe quality professionals have a responsibility to lead that change.If you’re passionate about improving the way clinical trials are run, you’re in the right place. Let’s raise the bar together.
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