| Hybrid in MA || GCP Supplier Quality Specialist || USC,GC,GC-EAD & H4-EAD at Remote, Remote, USA |
| Email: [email protected] |
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Job Title: GCP Supplier Quality Specialist Location: Hybrid (Cambridge, MA) Visa: USC/GC/GC-EAD/H4 Mode of Interview: Web-based Job Description: We are seeking an experienced and skilled GCP Supplier Quality Specialist to join our team. The ideal candidate will have advanced knowledge of pharmaceutical development, clinical trials, GCP/GVP regulations, and relevant global guidelines. This role requires a professional with a strong background in GCP-related quality assurance, the ability to conduct audits, and expertise in translating findings into corrective actions. Key Responsibilities: GCP Quality Assurance Expertise : Provide leadership and support for GCP quality assurance activities across clinical development programs. Regulatory Knowledge : Apply extensive knowledge of ICH GCP and applicable global regulations, including FDA, EU, MHRA, PMDA, and ICH guidelines. Audit & Compliance : Conduct, oversee, and manage GCP audits and inspections; provide recommendations for improvements and develop corrective action plans to mitigate risks to company safety and data integrity. Technical Writing : Prepare quality positions, audit reports, SOPs, and other related documentation, ensuring high standards for clarity, accuracy, and regulatory compliance. GCP Training : Ensure staff and vendors comply with GCP guidelines and provide training on GCP best practices and regulatory requirements. Supplier Quality Management : Develop and execute a clinical supplier quality program, including evaluations and audits of suppliers, ensuring adherence to GCP standards. Cross-Functional Collaboration : Work closely with clinical operations, data management, pharmacovigilance, and other departments to ensure GCP compliance across various functions. Global Travel : Participate in audits, regulatory inspections, and meetings as required. Willingness to travel both domestically and internationally is essential. Required Qualifications: Education : BA/BS degree required; Advanced Degree (e.g., MS, MBA, or PhD) preferred. Experience : Minimum 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 3 years in GCP Quality/Compliance. At least 7 years of direct experience in GCP-related Quality Assurance. Proven success in developing and implementing clinical or pharmacovigilance audit programs. Strong experience hosting or leading regulatory inspections and managing remediation activities on a global scale. Experience managing complex organizational compliance issues and implementing organization-wide compliance initiatives. Skilled in managing and leading global, cross-functional projects. Certifications : GCP Quality Assurance certification (or equivalent) preferred. Knowledge : Advanced knowledge of pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH guidelines. Deep understanding of GCP and relevant global regulations and guidance for clinical development. Expertise in audit conduct and reporting, translating audit findings into actionable corrective plans. Skills : Strong technical writing skills and ability to create clear, actionable audit reports, quality positions, and SOPs. Project management skills , with the ability to lead cross-functional, global projects. Excellent communication and interpersonal skills to collaborate effectively across teams and departments. Other Requirements : Routine demands of an office-based environment. Willingness to travel, including occasional international travel. Preferred Qualifications: Advanced GCP certifications. Experience with leading or managing a clinical or pharmacovigilance audit program globally. Regards, Steve Williams | Technical Recruiter | -- Keywords: business analyst information technology green card microsoft Massachusetts Hybrid in MA || GCP Supplier Quality Specialist || USC,GC,GC-EAD & H4-EAD [email protected] |
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| 10:53 PM 10-Jan-25 |