Current jobs related to Director of Quality Assurance and Pharmacovigilance - Waltham, Massachusetts - Alkermes, Inc.
-
Waltham, Massachusetts, United States GQR Full timeJob Title: Director, Clinical Quality Assurance, PharmacovigilanceJob Summary:GQR is seeking a highly experienced Director of Clinical Quality Assurance and Pharmacovigilance to lead our team in ensuring the highest standards of quality and safety in our pharmaceutical operations.Key Responsibilities:Develop and implement risk-based audit plans to ensure...
-
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionThe Director of Clinical Quality Assurance and Pharmacovigilance is a senior leadership position responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations. This role is responsible for developing and implementing strategies...
-
Medical Director, Drug Safety
3 weeks ago
Waltham, Massachusetts, United States Mythic Therapeutics Full timeJob Title: Director/Sr. Medical Director, Drug Safety & PharmacovigilanceJob Summary:The Director/Sr. Medical Director, Drug Safety & Pharmacovigilance will be responsible for the collection, detection, assessment, monitoring, and prevention of adverse effects with Company's drug candidates. This role will also oversee the strategic development and...
-
Medical Director, Pharmacovigilance Specialist
4 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Title: Medical Director, PharmacovigilanceJob SummaryDeciphera Pharmaceuticals, a member of ONO, is seeking a highly skilled Medical Director to lead our Pharmacovigilance team. As a key member of our organization, you will be responsible for ensuring the safety of our products and providing medical expertise to support our global operations.Key...
-
Senior Director of R&D Quality Assurance
1 month ago
Waltham, Massachusetts, United States Apellis Full timeJob Title: Senior Director of R&D Quality AssuranceApellis Pharmaceuticals, Inc. is seeking a highly experienced Senior Director of R&D Quality Assurance to lead our global R&D QA function. As a key member of our Quality Leadership Team, you will be responsible for establishing and implementing the strategy for R&D QA, ensuring compliance with global...
-
Pharmacovigilance Operations Manager
4 weeks ago
Waltham, Massachusetts, United States Apellis Full timeJob Title: Pharmacovigilance Operations ManagerApellis Pharmaceuticals, Inc. is seeking a highly skilled Pharmacovigilance Operations Manager to join our team. As a key member of our Pharmacovigilance department, you will be responsible for managing the day-to-day operations of our pharmacovigilance activities, ensuring compliance with regulatory...
-
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob SummaryDeciphera Pharmaceuticals is seeking a highly skilled Senior Manager, Pharmacovigilance Operations to lead the Pharmacovigilance department in providing direction for adverse event case management, study team support, and risk management collaboration. The ideal candidate will have a strong background in pharmacovigilance, experience with Argus...
-
Medical Director, Drug Safety
4 weeks ago
Waltham, Massachusetts, United States Mythic Therapeutics Full timeJob Title: Director/Sr. Medical Director, Drug Safety & PharmacovigilanceJob Summary:The Director/Sr. Medical Director, Drug Safety & Pharmacovigilance will be responsible for the collection, detection, assessment, monitoring, and prevention of adverse effects with Company's drug candidates. This role will also oversee the strategic development and...
-
Waltham, Massachusetts, United States Alkermes, Inc. Full timeJob OverviewThe Senior Medical Director/Global Safety Officer will provide strategic safety oversight for assigned investigational and/or marketed products within the Alkermes Neuroscience portfolio. This role will work closely with the DSPV leadership team and serve as a visible resource for safety advisement in company-wide forums and initiatives.The ideal...
-
Senior Director, R&D Quality Assurance Lead
1 week ago
Waltham, Massachusetts, United States Apellis Full timeJob OverviewApellis Pharmaceuticals is seeking a highly experienced Senior Director, R&D Quality Assurance to lead the development and implementation of quality strategies for the company's R&D function. The successful candidate will be responsible for establishing and maintaining a robust quality management system that ensures compliance with regulatory...
-
Senior Director of R&D Quality Assurance
1 month ago
Waltham, Massachusetts, United States Apellis Full timeJob Title: Senior Director, R&D QAJob Summary:The Senior Director of R&D Quality Assurance will be responsible for establishing and implementing the strategy for the R&D QA function at Apellis. This individual will partner with senior management and stakeholders to develop risk-based, phase-appropriate strategies to ensure that clinical trials and...
-
Director of Quality Assurance
2 weeks ago
Waltham, Massachusetts, United States RPM ReSearch Full timeJob SummaryThe Director of Quality Assurance is responsible for overseeing all aspects of the Quality Assurance function, including the development, implementation, and maintenance of an effective Quality Management System. This includes ensuring compliance with relevant regulations and standards, such as FDA and EMA guidelines.The ideal candidate will have...
-
Senior Director of Quality Assurance
4 weeks ago
Waltham, Massachusetts, United States TScan Therapeutics Full timeJob Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...
-
Senior Director of Quality Assurance
1 month ago
Waltham, Massachusetts, United States TScan Therapeutics Full timeJob Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...
-
Quality Assurance Associate III
1 week ago
Waltham, Massachusetts, United States PSG Global Solutions Careers Full timeJob DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Quality Assurance Associate III to join our team. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our global operations.Responsibilities:Support quality oversight across GPV GBUs on PV...
-
Director of Quality Assurance Operations
2 weeks ago
Waltham, Massachusetts, United States ElevateBio Full timeDirector of Quality Assurance OperationsElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to...
-
Director of Quality Assurance Operations
4 weeks ago
Waltham, Massachusetts, United States ElevateBio Full timeJob Title: Director of Quality Assurance OperationsElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and...
-
Director of Quality Operations
2 weeks ago
Waltham, Massachusetts, United States Mural Oncology Full timeJob Title: Director Quality OperationsMural Oncology is a clinical-stage oncology company focused on discovering and developing immunotherapies that may improve the lives of patients with cancer. Our team is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good...
-
Clinical Quality Assurance Manager
2 weeks ago
Waltham, Massachusetts, United States Lyra Therapeutics Full timeJob Title: Manager/Sr. Manager GCP Clinical Quality AssuranceLyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge technology...
-
Clinical Quality Assurance Manager
4 weeks ago
Waltham, Massachusetts, United States Lyra Therapeutics Full timeJob Title: Manager/Sr. Manager GCP Clinical Quality AssuranceLyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge research...
Director of Quality Assurance and Pharmacovigilance
2 months ago
The Director of Quality Assurance and Pharmacovigilance is a key leadership position at Alkermes, Inc. responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post-Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations.
Key Responsibilities:- Develop and Implement Quality Initiatives: Develop risk-based and current industry-standard annual audit planning focusing on in-coming safety data from all sources, compliant case processing and reporting, medical review, signal detection, risk management programs, and safety-related labeling.
- Conduct Quality Audits: Schedule, personally conduct, and/or manage quality audits for GPvP, Commercial Safety, and PDMA activities, ensuring compliance with regulatory requirements.
- Build and Manage Resources: Build and manage internal and external resources for quality audits and ongoing departmental oversight and partnerships, fostering collaboration and knowledge sharing.
- Regulatory Expertise: Serve as a Key Opinion Leader for GPvP and PDMA regulations, process strategies, and regulatory guidelines (domestic & international) for all related departments, providing expert guidance and support.
- Partnership Development: Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness, driving business growth and success.
- Audit Oversight: Provide oversight for and participate in audits of clinical safety and PV vendors, PV partners, electronic clinical and PV data systems, clinical and post-marketing PV documents, and internal systems relevant to safety data and regulatory reporting and sample management.
- Leadership and Development: Provide supervisory support, mentorship, and training to auditors and contract auditors, fostering their growth and development.
- Quality Assurance and Compliance: Provide quality assurance and compliance status of the company's Pharmacovigilance and PDMA systems to management and senior management, ensuring regulatory compliance and business integrity.
- Vendor Management: Assist in vendor selection, audit qualifications, oversight, and risk-based auditing of 3rd parties supporting GPvP, ensuring the quality and reliability of external partners.
- Audit Resolution: Collaborate with the Drug Safety group in follow-up to internal, vendor, specialty pharmacy, and partner audits to ensure resolution of audit findings, driving continuous improvement.
- Metrics and Reporting: Assist with the maintenance of tracking systems for all GCP/GPvP audit activity, develop and present periodic metrics and risk management to company leadership, informing business decisions.
- Regulatory Preparedness: Lead the preparation and conduct of mock and regulatory agency inspections and report responses, ensuring the company's readiness for regulatory scrutiny.
- Continuous Improvement: Identify gaps in systems and processes and implement procedures as part of continuous improvement, driving business excellence and growth.
- Education: Minimum bachelor's degree in nursing, pharmacy, or allied health/science.
- Experience: 15-20 years of pharmaceutical industry experience within the Quality/Compliance Oversight of Drug Safety, Clinical, Regulatory, and/or Medical Affairs disciplines.
- Regulatory Expertise: Experience in global GPvP regulations, Part 11 computer systems, all types of PV internal and external auditing.
- Industry Knowledge: Working knowledge of US, International Conference on Harmonization (ICH), and EU GPvP regulations and guidelines.
- Interpersonal Skills: Good interpersonal skills and excellent oral and written communication skills.
- Technical Skills: Knowledge of safety and sample management systems (e.g. Argus, ARISg, Trial Works, and IMPACT) as well as standard tracking databases (e.g., Track Wise).
- Frequency: 20-30% travel required.
