Associate Director, Research & Clinical Development QA

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

Job summary

A leading biopharmaceutical company is seeking an Associate Director for Research & Clinical Development QA. This role involves overseeing quality assurance for clinical trials, ensuring compliance, and managing QA activities with third party vendors. Ideal candidates will have significant experience in GVP Quality Assurance and auditing. Join a team dedicated to improving patient lives through innovative therapies.

Qualifications

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

Responsibilities

• Oversee QA activities for compliance with regulatory inspections.
• Develop the R&CD QA function for clinical trials.
• Manage relationships with internal and external stakeholders.

Skills

Communication

Writing

Presentation

Education

Bachelor’s degree in Regulatory Affairs

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 a to the Drug Safety and Pharmacovigilance team, the QPPV, and Blueprint QA
• 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;
• 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;
• Oversee and assess GVP processes to ensure continued safety and compliance;
• 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;
• Manage all 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, strategies, and processes;
• Review and develop SOPs, other controlled documents, and training courseware for DSPV teams;
• Oversee development of risk-based DSPV-related auditing schedules and internal and external inspection readiness activities;
• Direct the DSPV vendor audit, internal audit, and inspection procedures and address audit observations;
• Present the DSPV QA activities during regulatory inspections and support QA organizations during regulatory inspections;
• Review and provide QA support for maintenance of 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 reporting of Quality Metrics;
• Develop, manage, implement, and improve internal Quality Management System for DSPV;
• Approve deviations and Corrective and Preventive Actions (CAPAs), perform investigations and root cause analysis;
• Review and approve Safety SOPs, WI, guidelines, training compliance and regulatory compliance;
• Oversee generation and review of documents used in DSPV activities;
• 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:

• 5 years of experience working in Clinical Quality Assurance for sponsor companies, CROs, and/or Drug safety auditing.
• 2 years of experience auditing/inspections under EU and/or FDA regulations.
• 4 years of experience in providing logistic and execution support for Regulatory Authority GVP Inspections.
• 2 years of experience in auditing Pharmacovigilance (GVP), Clinical Research (GCP), Regulatory affairs, quality assurance and GxP auditing.
• Excellent knowledge of Global Drug safety and Pharmacovigilance regulations and industry standards.
• Excellent communication, writing and presentation skills.

What additional qualifications will make you a stronger candidate?

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

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

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

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

At Blueprint Medicines, we foster an environment of fair treatment and full participation for all of our employees as we navigate complex challenges in pursuing our mission to improve the lives of patients. We celebrate our unique differences and varied career and life experiences so that we can sustain our diverse culture and ensure everyone feels accepted. We are committed to non-discrimination, equal employment opportunity, as well as an inclusive recruitment process. We consider all qualified applicants based on merit and without regard to race, color, sex, gender identity, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable federal or state law.

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

* This position is part of Blueprint Medicines’ employee referral program and is eligible for an employee referral incentive bonus.

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