Associate Director, Research & Clinical Development QA

Blueprint Medicines Co.; Cambridge (MA); Remote; USD 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company in Cambridge seeks an Associate Director for Research & Clinical Development QA. This role involves overseeing quality assurance for drug safety and pharmacovigilance, ensuring compliance with regulations, and managing audits. The ideal candidate will have a strong background in regulatory affairs and quality assurance, with excellent communication skills. Join a team dedicated to inventing life-changing medicines and making a significant impact on patient care.

Benefits

Referral bonus

Qualifications

• 5 years in a GVP Quality Assurance role.
• 2 years in auditing/inspections under EU and/or FDA regulations.

Responsibilities

• Oversee the quality assurance of all GVP activities.
• Manage DSPV vendor audits, internal audits, and inspections.
• Develop and improve the internal Quality Management System for DSPV.

Skills

Communication

Writing

Presentation

Education

Bachelor’s degree in Regulatory Affairs

Bachelor’s degree in Pharmaceutical Science

Job description

Associate Director, Research & Clinical Development QA

Cambridge, MA, United States

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?

• Provide QA support to the Drug Safety and Pharmacovigilance team, the QPPV, and Blueprint QA.
• Oversee the QA activities of DSPV activities at Blueprint Medicines to ensure compliance and readiness for Sponsor and Regulatory Inspections.
• Utilize expertise in Regulatory Affairs and Pharmaceutical Science to ensure proper processes, systems, and activities are in place to protect clinical patients' rights, safety, and welfare.
• Oversee and assess GVP processes for safety and compliance.
• Develop the R&CD QA function to ensure high-quality execution of clinical trials from first-in-human to commercial marketing authorization, including pharmacovigilance activities post-commercialization.
• Manage cross-functional relationships with internal and external stakeholders.
• Serve as the expert and point of contact for all Quality Assurance, DVSP, and QPPV teams.
• Support DSPV training programs to align with company quality objectives and strategies.
• Review and develop SOPs, controlled documents, and training materials for DSPV teams.
• Oversee development of risk-based DSPV-related audit schedules and inspection readiness activities.
• Manage DSPV vendor audits, internal audits, and inspections, addressing observations as needed.
• Represent DSPV QA activities during regulatory inspections and support QA during inspections.
• Review and support maintenance of the Pharmacovigilance System Master File (PSMF) and Safety Data Exchange Agreement (SDEA).
• Identify and escalate critical DSPV findings to Senior Management.
• Track Key Process Indicators (KPIs) for quality metrics reporting.
• Develop, implement, and improve the internal Quality Management System for DSPV.
• Approve deviations, CAPAs, perform investigations, and root cause analyses.
• Review and approve Safety SOPs, work instructions, guidelines, and ensure training and regulatory compliance.
• Oversee document generation and review for DSPV activities.
• Utilize expertise to interpret regulations applicable to DSPV and provide guidance on 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), plus 5 years of experience in a GVP Quality Assurance role.

Experience, which may be gained concurrently, must include:

• 5 years in Clinical Quality Assurance for sponsor companies, CROs, or drug safety auditing.
• 2 years in auditing/inspections under EU and/or FDA regulations.
• 4 years supporting Regulatory Authority GVP Inspections logistics and execution.
• 2 years in auditing Pharmacovigilance (GVP), Clinical Research (GCP), Regulatory affairs, or GxP auditing.
• Excellent knowledge of global drug safety and pharmacovigilance regulations and standards.
• Strong communication, writing, and presentation skills.

What additional qualifications will strengthen your candidacy?

• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

Why Blueprint?

At Blueprint Medicines, we achieve impactful results through our compassionate, innovative Blue Crew. We foster authentic relationships, entrepreneurial spirit, and ownership, empowering our team to break norms using their strengths and insights, driving success.

This is where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

We promote a diverse, inclusive environment, ensuring fair treatment and participation for all employees. We are committed to non-discrimination and equal opportunity, considering all qualified applicants based on merit.

Blueprint Medicines is a global biopharmaceutical company dedicated to inventing life-changing medicines, focusing on allergy/inflammation and oncology/hematology. We aim to alleviate human suffering by targeting disease root causes, leveraging scientific knowledge and drug discovery expertise. Our success includes approved medicines for systemic mastocytosis and a broad pipeline from early science to clinical trials in various diseases.

* This position is part of our employee referral program and is eligible for a referral bonus.