Director of Quality Assurance and Regulatory Affairs Jobs in Somerville, MA
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA (1 mile from Somerville, MA)
- 10 hours ago
- Cambridge, MA (1 mile from Somerville, MA)
- 10 hours 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...
Senior Manager, Regulatory Affairs Device
- Cambridge, MA (1 mile from Somerville, MA)
- 1 day ago
- Cambridge, MA (1 mile from Somerville, 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...
Director / Sr. Director, Regulatory Affairs
- Waltham, MA (8 miles from Somerville, MA)
- 1 day ago
- Waltham, MA (8 miles from Somerville, MA)
- 1 day ago
DIRECTOR/SENIOR DIRECTOR, REGULATORY AFFAIRS Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the teams...
Lab Manager - Center for Genomic Medicine
- Boston, MA (2 miles from Somerville, MA)
- 5 days ago
- Boston, MA (2 miles from Somerville, MA)
- 5 days 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 (2 miles from Somerville, MA)
- 5 days ago
- Boston, MA (2 miles from Somerville, MA)
- 5 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 (2 miles from Somerville, MA)
- 10 days ago
- Boston, MA (2 miles from Somerville, MA)
- 10 days ago
Conducts immunohistochemistry, microscopy, and molecular biology techniques such as sequencing and PCR....
Sr. Manager, Regulatory Affairs Strategy
- Waltham, MA (8 miles from Somerville, MA)
- 10 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 10 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 (2 miles from Somerville, MA)
- 12 days ago
- Boston, MA (2 miles from Somerville, MA)
- 12 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 (2 miles from Somerville, MA)
- 12 days ago
- Boston, MA (2 miles from Somerville, MA)
- 12 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 (1 mile from Somerville, MA)
- 12 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 12 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 (1 mile from Somerville, MA)
- 13 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 13 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 (8 miles from Somerville, MA)
- 13 days ago
- Lexington, MA (8 miles from Somerville, MA)
- 13 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 Somerville, MA)
- 16 days ago
- Burlington, MA (10 miles from Somerville, MA)
- 16 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...
Manager, Quality Assurance Operations
- Framingham, MA (17 miles from Somerville, MA)
- 18 days ago
- Framingham, MA (17 miles from Somerville, MA)
- 18 days ago
Overview Replimunes mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (1 mile from Somerville, MA)
- 19 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 19 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 WorkDemographic Data for Somerville, MA
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Somerville, MA 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
- 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
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- 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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