Manager of Quality Assurance and Regulatory Affairs Jobs in Andover, 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.
Lab Manager - Center for Genomic Medicine
- Boston, MA (20 miles from Andover, MA)
- 1 day ago
- Boston, MA (20 miles from Andover, MA)
- 1 day ago
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 (20 miles from Andover, MA)
- 2 days ago
- Boston, MA (20 miles from Andover, MA)
- 2 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,...
Research Lab Manager RESEARCH NEUROLOGY Butovsky Lab
- Boston, MA (20 miles from Andover, MA)
- 6 days ago
- Boston, MA (20 miles from Andover, MA)
- 6 days ago
Conducts immunohistochemistry, microscopy, and molecular biology techniques such as sequencing and PCR....
Associate Director, Regulatory Affairs (mRNA vaccines)
- Waltham, MA (18 miles from Andover, MA)
- 7 days ago
- Waltham, MA (18 miles from Andover, MA)
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Sr. Manager, Regulatory Affairs Strategy
- Waltham, MA (18 miles from Andover, MA)
- 7 days ago
- Waltham, MA (18 miles from Andover, MA)
- 7 days ago
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical...
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
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 missionfrom doctors, nurses, business people and...
Research Lab Manager BWH Neurology Fox Lab
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
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 missionfrom doctors, nurses, business people and...
Director, Regulatory Affairs, Specialty
- Cambridge, MA (18 miles from Andover, MA)
- 9 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 9 days ago
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...
Associate Director, Regulatory Affairs
- Cambridge, MA (18 miles from Andover, MA)
- 10 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 10 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 Director, Quality Assurance
- Lexington, MA (13 miles from Andover, MA)
- 10 days ago
- Lexington, MA (13 miles from Andover, MA)
- 10 days ago
Senior Director, Quality Assurance Reporting to the VP, Head of Quality, the Senior Director, Quality Assurance, will be responsible for creating/monitoring and maintaining phase appropriate ICH...
Senior Manager, Quality Assurance
- Burlington, MA (10 miles from Andover, MA)
- 12 days ago
- Burlington, MA (10 miles from Andover, MA)
- 12 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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (18 miles from Andover, MA)
- 16 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 16 days ago
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our...
Remote WorkMore about You B.S. degree in Biology or Biochemistry with course work emphasizing analytical molecular biology techniques. Additional training in cell biology is a plus....
Senior Manager, Regulatory Affairs, Operations
- Boston, MA (20 miles from Andover, MA)
- 20 days ago
- Boston, MA (20 miles from Andover, MA)
- 20 days ago
Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the...
Associate Director, Regulatory Affairs Vaccines CMC
- Boston, MA (20 miles from Andover, MA)
- 21 days ago
- Boston, MA (20 miles from Andover, MA)
- 21 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Demographic Data for Andover, MA
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Andover, 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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