This position is responsible for quality and compliance oversight of Boston Biomedical oncology clinical trials with drug products including small molecules, peptides and drug delivery devices. This role includes oversight of Clinical Research Organizations (CROs), Local and Central Clinical Testing Laboratories, Biomarker Research and Diagnostics Laboratories, and Principal Investigator sites. Thorough understanding of international current good clinical practices (cGCPs), and good clinical laboratory practices (GCLP) for both drug and devices, as well as other best practices for pharmaceutical drug development is a critical component of this role. Quality support will be provided to internal and external groups performing pharmacovigilance, data management and data analysis. This Quality function supports early and late stage clinical programs as well as NDA filings and inspection readiness. The role will partner with internal stakeholders and external service providers to ensure BBI maintains the highest levels data integrity.
- Quality support and contact/interface with Boston Biomedical Clinical Development, Operations, Pharmacovigilance, Data Management and partners that are based in the US, Japan and other global locations
- Responsible for qualification of CROs, Clinical Laboratories, GxP Software systems and other service providers involved in Boston Biomedical sponsored Clinical Research
- Responsible for assessing and approving deviations, investigations and CAPAs
- Coordinates and leads audits of CROs, Clinical Investigation Sites, Pharmacies, Clinical Laboratories and suppliers of critical services
- Responsible for serving as the Quality representative on Clinical Project Teams
- Review and conduct Quality Control Checks of Clinical Study Reports and regulatory submissions and other critical documents.
- Provide guidance and direction on procedures and requirements for meeting applicable GCP and GLP regulations and standards. Writes standards and SOPs related to Clinical Quality.
- Handles product quality complaints, provides reports to safety committees and reconciles with adverse events
- Manage contractors and consultants providing GCP support to Boston Biomedical standards.
- Support a culture of quality and collaboration across the company.
- Monitors industry trends and regulatory intelligence to ensure evolution of the GCP compliance strategy and data integrity practices.
- Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.
- Assist in the management of regulatory agency inspections both at Boston Biomedical and clinical sites, laboratories and CROs.
- Other duties as needed.
- Bachelor’s degree in Biology, Chemistry, Nursing, Medical Technology or related scientific discipline required; Advanced degree (MS, MBA) preferred.
- 5-8 years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a GCP-related role.
- GCP oversight experience working in a CRO, Clinical Laboratory or Clinical Investigator’s site desired.
- Knowledge of FDA, International and current industry standards for Data Integrity
- Practical understanding of global patient privacy laws
- Experience with electronic document management and quality systems a plus
- Must have knowledge of FDA and international guidelines and have a proven track record in implementing these guidelines in fast growing environments.
- Experience in building GCP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
- Experience with external CRO and contract laboratories as a part of a virtual company
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Drug/Device Combination Product experience desired
- Experience with Oncology drugs desired
- Possess strong conflict management and negotiation skills.
- Excellent verbal and written communication skills
- Self-motivated, able to work independently and be reliable and responsive
- Travel domestic and international approximately 15-20%
Job Location: Cambridge, MA
Please send resumes to email@example.com
Equal Opportunity Employer
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