About Verastem Oncology
Embracing the power of partnership and collaboration to develop novel cancer therapies. Backed by Foresite Capital.
About the role
Verastem Oncology is hiring a Associate Director, Quality GCP in Boston, Massachusetts. The full description is on Verastem Oncology's site.
What they're looking for
- Bachelor’s degree in related Life Sciences discipline is required , advanced degree preferred
- 7 + years in drug/ biologics development in the biotechnology or pharmaceutical industry
- 4 years previous GCP Quality Assurance experience in Clinical Research and Development
- Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities
- In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines
- Strong working knowledge/experience in planning, conducting and reporting clinical site and service provider audits
More about this role
- Develop and implement Quality Programs where needed
- Develop and implement risk-based GCP strategies across clinical programs and/or studies
- Manage and/or actively support the development, enhancement, review, and implementation of GCP quality standards, and controlled documents (e.g., SOPs, Work Instructions, Templates)
- Promote compliance and quality throughout the company and represent in Quality Department in internal meetings and events.
- Build, develop, and maintain working relationships with internal and external partners.
- Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Form.
- Plan, conduct and manage audits of clinical trial sites, vendors, and/or internal processes, and associated follow-up activities (e.g., reports, corrective actions) . For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.
- Partner with clinical internal stakeholders to manage clinical vendor and/or clinical site oversight and/or issue management.
- Conduct and/or facilitate investigations...
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