Associate Director, Research & Clinical Development QA

How will your role help us transform hope into reality?

Oversee the quality assurance of all Good Pharmacovigilance Practice (GVP) activities to ensure that third party vendors remain compliant with and prepared for potential Sponsor and Regulatory Inspections, and ensure that the appropriate processes, systems, and activities are in place and performed to protect the rights, safety and welfare of patients participating in clinical trials.

What will you do?

1. Provide QA support a to the Drug Safety and Pharmacovigilance team, the QPPV, and Blueprint QA 
2. Oversee the QA activities of DSPV activities at Blueprint Medicines to ensure that all third party vendors remain compliant with and prepared for potential Sponsor and Regulatory Inspections; 
3. Utilize expertise in Regulatory Affairs and Pharmaceutical Science to ensure that the appropriate processes, systems, and activities are in place and performed both internally and externally to protect the rights, safety and welfare of clinical patients; 
4. Oversee and assess GVP processes to ensure continued safety and compliance; 
5. Develop the R&CD QA function to ensure high quality execution of clinical trials from first in human through commercial marketing authorization, and the pharmacovigilance activities following commercialization; 
6. Manage all cross functional relationships with internal and external stakeholders; 
7. Serve as the expert and point of contact for all Quality Assurance, DVSP, and QPPV teams; 
8. Support DSPV training programs to align with company quality objectives, strategies, and processes;  
9. Review and develop SOPs, other controlled documents, and training courseware for DSPV teams; 
10. Oversee development of risk-based DSPV-related auditing schedules and internal and external inspection readiness activities; 
11. Direct the DSPV vendor audit, internal audit, and inspection procedures and address audit observations; 
12. Present the DSPV QA activities during regulatory inspections and support QA organizations during regulatory inspections; 
13. Review and provide QA support for maintenance of Pharmacovigilance System Master File (PSMF) and Safety Data Exchange Agreement (SDEA); 
14. Identify and escalate critical DSPV findings to Senior Management; 
15. Track Key Process Indicators (KPIs) for reporting of Quality Metrics; 
16. Develop, manage, implement, and improve internal Quality Management System for DSPV; 
17. Approve deviations and Corrective and Preventive Actions (CAPAs), perform investigations and root cause analysis; 
18. Review and approve Safety SOPs, WI, guidelines, training compliance and regulatory compliance; 
19. Oversee generation and review of documents used in DSPV activities; 
20. Utilize expertise to interpret regulations as they apply to DSPV and provide guidance to the DSVP and QA teams on specific regulatory frameworks, including EU GVP, and FDA. 

 

May telecommute from any location in the US. 

 

What minimum qualifications do we require?

Bachelor’s degree in Regulatory Affairs, Pharmaceutical Science or a related field (or foreign equivalent degree), plus 5 years of experience in working in a quality role in GVP Quality Assurance.   

 

Experience, which may be gained concurrently, must include: 

1. 5 years of experience working in Clinical Quality Assurance for sponsor companies, CROs, and/or Drug safety auditing. 

1. 2 years of experience auditing/inspections under EU and/or FDA regulations. 

1. 4 years of experience in providing logistic and execution support for Regulatory Authority GVP Inspections. 

1. 2 years of experience in auditing Pharmacovigilance (GVP), Clinical Research (GCP), Regulatory affairs, quality assurance and GxP auditing. 

1. Excellent knowledge of Global Drug safety and Pharmacovigilance regulations and industry standards. 

1. Excellent communication, writing and presentation skills.  

 

What additional qualifications will make you a stronger candidate?

• Commitment to our Core Values: Patients First, Thoughtfulness,