Mindlance
USA - Quality Compliance Specialist
This job is now closed
Job Description
- Req#: 25-45972
- Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
- Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
- Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Takeda’s values and strategic priorities.
- 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 in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
- Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
- Skilled in managing global, cross-functional projects.
Actual job title: Clinical Quality Compliance Lead
Location:
Hybrid role, 2 days per week on-site
Start Date is in January for about 1 – 1.5 years.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”About the company
Mindlance is one of the largest diversity-owned staffing firms in the US . As a recruitment centric talent acquisition company, Mindlance provides Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional and Payroll Management staffing services to Global 1000 companies across the US, Canada and India.
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