Director of Quality Assurance and Regulatory Affairs Jobs in Westborough, 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.
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA (23 miles from Westborough, MA)
- 16 hours ago
- Bedford, MA (23 miles from Westborough, MA)
- 16 hours 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...
- Lexington, MA (24 miles from Westborough, MA)
- 1 day ago
- Lexington, MA (24 miles from Westborough, MA)
- 1 day ago
We are seeking a dedicated and experienced Lab Manager to support both the Biology and Chemistry teams by ensuring a safe, efficient, and well-organized working environment. The Lab Manager will...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (17 miles from Westborough, MA)
- 8 days ago
- Wellesley Hills, MA (17 miles from Westborough, MA)
- 8 days ago
Sr. Manager, Regulatory Affairs About Climb Bio: Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates...
Preferred: Specialized knowledge of niche topics such as cell therapy, cell culture, QC methods, auditing techniques, barcoding, HEPA filtration science, etc....
Director, Quality Assurance GMP Operations
- Milford, MA (8 miles from Westborough, MA)
- 17 days ago
- Milford, MA (8 miles from Westborough, MA)
- 17 days ago
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...
Senior Director, Regulatory Affairs
- Waltham, MA (20 miles from Westborough, MA)
- 21 days ago
- Waltham, MA (20 miles from Westborough, MA)
- 21 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...
Associate Director, Quality Assurance Vendor Management
- Watertown, MA (22 miles from Westborough, MA)
- 30+ days ago
- Watertown, MA (22 miles from Westborough, MA)
- 30+ days ago
biology, specifically heme biosynthesis and iron homeostasis....
Remote WorkSenior Director, Quality Assurance
- Lexington, MA (24 miles from Westborough, MA)
- 45+ days ago
- Lexington, MA (24 miles from Westborough, MA)
- 45+ 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...
Demographic Data for Westborough, MA
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Director of Quality Assurance and Regulatory Affairss in Westborough, 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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