Specialist in Audit and Quality leading audits and ensuring compliance with ISO standards for Pearson Education. Collaborating with stakeholders to drive continual improvement in business processes and quality.
About the role
- Associate Director ensuring quality compliance in clinical and safety processes for a global pharmaceutical. Involved in regulatory intelligence, change control, and continuous improvement initiatives.
Responsibilities
- Ensure compliance to Regulatory Intelligence Procedures
- Execute the regulatory intelligence process in partnership with compliance teams
- Implement change control for new and revised regulations
- Oversee reviews and closure of routine and complex change controls
- Provide data insights to emerging regulations and compliance metrics
- Participate in enterprise-wide projects and initiatives
- Support implementation of new and revised processes across CPMQ
- Contribute to the Clinical and Safety Quality Compliance strategy as part of the Leadership Team
Requirements
- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry
- At least 3 years of experience in GCP Quality/Compliance
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
- Successful development and implementation of a clinical or pharmacovigilance audit program
- Experience hosting/leading regulatory inspections and remediation activities on a global level
- Skilled in managing global, cross-functional projects
- Successful management of business transformation/change management initiatives
- Excellent communication skills and active listening skills
- Outstanding problem-solving abilities
- Fluency in written and spoken English, additional language skills a plus
Benefits
- Medical, dental, vision insurance
- 401(k) plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- Up to 120 hours of paid vacation for new hires
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Specialist for Audit and Quality at Pearson ensuring compliance with ISO standards and driving process improvements by leading audits.
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