Manager of Quality Assurance and Regulatory Affairs Jobs in Massachusetts
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.
With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy....
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...
Associate Director, Quality Assurance Vendor Management
- Watertown, MA
- 2 days ago
- Watertown, MA
- 2 days ago
biology, specifically heme biosynthesis and iron homeostasis....
Remote WorkAssociate Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA
- 4 days ago
- Bedford, MA
- 4 days ago
Ability to understand and interpret clinical trial data....
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA
- 5 days ago
- Cambridge, MA
- 5 days ago
development programs and marketed products Prior experience with IND & BLA submissions strongly preferred Prior experience managing regulatory staff and department budgets Pharm.D, M.D or Ph.D. in biochemistry...
Supports products registrations and acts as the regulatory affairs lead for clinical trial activities for multiple programs....
QUALIFICATIONS: Bachelor's degree required in a research related field, with some experience performing molecular biology techniques (e.g. bacterial culture, molecular cloning, human cell culture, DNA...
Senior Director, Regulatory Affairs Advertising & Promotion (Remote)
- Boston, MA
- 10 days ago
- Boston, MA
- 10 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,...
Our client in Western Massachusetts is seeking an e xperienced Core Laboratory Manager. Enjoy a full-time permanent opportunity that offers competitive compensation and excellent benefits. The...
Conducts immunohistochemistry, microscopy, and molecular biology techniques such as sequencing and PCR....
Lead the preparation of lifecycle submissions, which may include IND amendments, Annual Reports, Meeting Documents, Special Designations, and Clinical Trial Applications....
Summary: In collaboration with the Patient Care Director the Clinical Nurse Manager evaluates the delivery of patient care using the organization's quality metrics monitors and reports trends in...
Experience working in Epic or other electronic medical record (EMR) system and fundamental knowledge of the conduct of clinical trials is preferred....
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...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
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Manager 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 Manager of Quality Assurance and Regulatory Affairs position
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Flow Cytometry
- Real-Time Polymerase Chain Reaction
- Transfection
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Drug Development
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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