Director of Quality Assurance and Regulatory Affairs Jobs in Massachusetts
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.
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...
About this opportunity : The Director, Quality Assurance GMP Operations is responsible for quality oversight of the manufacturing process and operations. This includes leading and managing...
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Key Responsibilities: Laboratory Maintenance: + Conduct daily assessments to ensure lab safety, including monitoring workspace conditions, checking freezer/refrigerator temperatures, inspecting growth...
Senior Director, Regulatory Affairs Regulatory - Waltham, Massachusetts Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's...
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...
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
- 11 days ago
- Burlington, 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...
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
- 15 days ago
- Boston, 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,...
Qualifications: Bachelor's degree in biology, chemistry, or a related field; advanced degrees preferred....
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 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...
Associate Director, Quality Assurance Vendor Management
- Watertown, MA
- 27 days ago
- Watertown, MA
- 27 days ago
biology, specifically heme biosynthesis and iron homeostasis....
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Director 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 Director 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
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- 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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