Mandy Cooke is the driving force behind Compliance-Science, bringing over 30 years of specialized experience in GxP quality and regulatory affairs to the healthcare and pharmaceutical sectors. She is also an accredited auditor in key ISO QMS Standards (ISO 9001:2015 and ISO 13485:2016).

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Whether you’re launching a new product, transforming your quality systems, or ensuring strategic regulatory implementation, Mandy’s visionary leadership and proven track record ensure compliance success.

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A Leader in Quality and Regulatory Excellence

Recognized as an authority in her field, Mandy has made significant contributions to the pharmaceutical industry. Her career highlights include:

• Transforming Quality Standards: Mandy improved business efficiency and ensured compliance by redefining quality management standards for a leading Consumer Health organization, aligning them with the diverse needs of products ranging from medicines to food supplements.

• Leading GSK’s Quality Management Transformation: Mandy spearheaded GSK’s ambitious 5-year initiative to overhaul their Quality Management System and compliance framework, driving innovation and strengthening regulatory adherence.

• Decade-Long Consultancy Success: As the head of her regulatory consultancy, Mandy successfully led numerous EU Marketing Authorization applications, solidifying her reputation as a trusted regulatory expert.

• Strategic Leadership in Global Pharma: Mandy has held key leadership roles across global pharmaceutical companies, where she shaped product quality, regulatory affairs, and compliance strategies.

 

Certified Change Leader and Strategic Consultant

Mandy’s expertise is further enhanced by her recent master’s in organizational psychology, which informs her user-centred approach to achieving compliance efficiently. With a BSc in Chemistry and a PhD in Organic Chemistry, Mandy combines deep scientific expertise with a unique ability to lead transformative change initiatives.