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.
Senior Manager, Regulatory Affairs
- Cambridge, MA (18 miles from Andover, MA)
- 1 day ago
- Cambridge, MA (18 miles from Andover, MA)
- 1 day 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
- Boston, MA (20 miles from Andover, MA)
- 4 days ago
- Boston, MA (20 miles from Andover, MA)
- 4 days ago
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 (18 miles from Andover, MA)
- 5 days ago
- Waltham, MA (18 miles from Andover, MA)
- 5 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 (20 miles from Andover, MA)
- 7 days ago
- Boston, MA (20 miles from Andover, MA)
- 7 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 (18 miles from Andover, MA)
- 9 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 9 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 (10 miles from Andover, MA)
- 11 days ago
- Burlington, MA (10 miles from Andover, MA)
- 11 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...
Research Lab Manager BWH Neurology F Lab
- Boston, MA (20 miles from Andover, MA)
- 11 days ago
- Boston, MA (20 miles from Andover, MA)
- 11 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 mission-from doctors, nurses, business people and...
Senior Director, Regulatory Affairs Advertising & Promotion
- Boston, MA (20 miles from Andover, MA)
- 15 days ago
- Boston, MA (20 miles from Andover, MA)
- 15 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 (18 miles from Andover, MA)
- 20 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 20 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 (18 miles from Andover, MA)
- 22 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 22 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...
Associate Director, Regulatory Affairs
- Boston, MA (20 miles from Andover, MA)
- 26 days ago
- Boston, MA (20 miles from Andover, MA)
- 26 days ago
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 (19 miles from Andover, MA)
- 27 days ago
- Watertown, MA (19 miles from Andover, MA)
- 27 days ago
biology, specifically heme biosynthesis and iron homeostasis....
Remote WorkAssociate Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA (11 miles from Andover, MA)
- 29 days ago
- Bedford, MA (11 miles from Andover, MA)
- 29 days ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA (18 miles from Andover, MA)
- 29 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 29 days ago
, biology, pharmacy, or related pharmaceutical fields including biochemical engineering....
Senior Manager, Regulatory Affairs Device
- Cambridge, MA (18 miles from Andover, MA)
- 30+ days ago
- Cambridge, MA (18 miles from Andover, MA)
- 30+ 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...
Demographic Data for Andover, MA
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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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- 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
- Leadership
- Communication Skills
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