Manager of Quality Assurance and Regulatory Affairs Jobs in Boston, MA
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (3 miles from Boston, MA)
- 16 hours ago
- Cambridge, MA (3 miles from Boston, MA)
- 16 hours ago
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote WorkAssociate Director, Regulatory Affairs CMC
- Cambridge, MA (3 miles from Boston, MA)
- 2 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 2 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
MGH Cardiac Surgery Large Animal Laboratory -- Levine Lab -- Lab Manager
- Boston, MA
- 3 days ago
- Boston, MA
- 3 days ago
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech...
Senior Manager, Regulatory Affairs (Clinical) Req #306 Boston, MA, USA Job Description Posted Wednesday, January 15, 2025 at 4:00 AM Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a...
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Senior Manager, Regulatory Affairs
- Cambridge, MA (3 miles from Boston, MA)
- 6 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 6 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Senior Director, Regulatory Affairs
- Waltham, MA (10 miles from Boston, MA)
- 10 days ago
- Waltham, MA (10 miles from Boston, MA)
- 10 days ago
Senior Director, Regulatory Affairs Regulatory - Waltham, Massachusetts Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA
- 12 days ago
- Boston, MA
- 12 days ago
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned...
Executive Director, Regulatory Affairs Strategy
- Cambridge, MA (3 miles from Boston, MA)
- 14 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 14 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Senior Manager, Regulatory Affairs - Biologics
- Burlington, MA (12 miles from Boston, MA)
- 16 days ago
- Burlington, MA (12 miles from Boston, MA)
- 16 days ago
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment...
Site: The Brigham and Women's Hospital, Inc. At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and...
Senior Director, Regulatory Affairs Advertising & Promotion
- Boston, MA
- 20 days ago
- Boston, MA
- 20 days ago
Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development,...
- Cambridge, MA (3 miles from Boston, MA)
- 25 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 25 days ago
This is a 100% Onsite position in Cambridge, MA location. Candidates must be local. Please do not submit re-location candidates. There are four development laboratories at AMA within scope of the...
Director, Quality Assurance Operations
- Cambridge, MA (3 miles from Boston, MA)
- 27 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 27 days ago
Director, Quality Assurance Operations Cambridge, MA Clinical Development, Quality Job Type Full-time Description Title: Director Quality Assurance Operations Marengo Therapeutics is pioneering...
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...
Demographic Data for Boston, MA
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Boston, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Affirmative Action
- Quality Systems
- Implementation
- Resolution
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Bioinformatics
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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