Director of Quality Assurance and Regulatory Affairs Jobs in Massachusetts
Sr Manager Quality Assurance, Device Supplier Management and Oversight
- Boston, MA
- 20 hours ago
- Boston, MA
- 20 hours ago
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology....
Understanding of the drug development process, FDA/EMA regulations and ICH guidance. Expert proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat....
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We...
Job Summary The Channing Division of Network Medicine (CDNM) focuses on network medicine and systems biology approaches to complex diseases....
Associate Director, Quality Assurance Document Control Management
- Woburn, MA
- 8 days ago
- Woburn, MA
- 8 days ago
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right...
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA
- 9 days ago
- Cambridge, MA
- 9 days ago
Prior involvement in metabolic diseases, immunology, or rare disease drug development is highly desirable....
Job Listing ID: 4305996 Job Title: Director Quality Assurance Application Deadline: Open Until FilledJob Location: Salem Date Posted: 07/05/2025Hours Worked Per Week: Not Provided Shift: Not...
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the teams activities from IND-enabling studies and...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA
- 10 days ago
- Boston, MA
- 10 days ago
Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment....
Review documentation and prepare drug development activity of pre-IND and IND submissions....
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
Reviews sections of IND, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements....
Candidates should demonstrate excellent understanding of drug development and leadership behaviors consistent with level....
Undergraduate/associate degree in biology, related science or equivalent with at least 4-5 years of relevant experience in hospital, academic or industry setting....
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Animal Models
- Neurobiology
- Gene Therapy
- Proteomics
- Batch Record Review
- Institutional Review Board
- TrackWise
- Clinical Laboratory Operations
- Lab Safety
- ICH Guidelines
- Immunohistochemistry
- Immunology
- Laboratory Information Management System
- Drug Development
- Experimental Design
- GxP
- Quality Systems
- Quality Management Systems
- Good Laboratory Practice
- Biochemistry
- Molecular Biology
- Biotechnology
- Laboratory Management
- Microbiology
- Medical Device Sales
- Biology
- Corrective Actions & Preventive Actions
- Clinical Trials
- Good Manufacturing Practices
- Research and Development
- Quality Management
- Inspections
- FDA Regulations
- Standard Operating Procedures
- Masters In Education
- Continuous Improvement
- Engineering
- Strategy Development
- Affirmative Action
- Implementation
- Quality Control
- Auditing
- Investigation
- Collaboration
- Documentation
- Mentoring
- Education Experience
- Reporting
- Quality Assurance
- Inventory Management
- Policy Development
- Coaching
- Problem Solving
- Bachelor's Degree
- Regulations
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Spectrophotometer
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