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
Job title
Associate Director, Clinical and Safety Quality Compliance
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