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.
Director, Quality Assurance Operations Cambridge, MA Clinical Development, Quality Job Type Full-time Description Title: Director Quality Assurance Operations Marengo Therapeutics is pioneering...
Your Purpose Alpha-9 Oncology is seeking a highly motivated Manager/Senior Manager, Quality Assurance with a strong GMP background to join our growing team. As a clinical-stage biotech focused on...
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
- 6 days ago
- Watertown, MA
- 6 days ago
biology, specifically heme biosynthesis and iron homeostasis....
Remote WorkAssociate Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA
- 7 days ago
- Bedford, MA
- 7 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
- 8 days ago
- Cambridge, MA
- 8 days 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...
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...
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
- 13 days ago
- Boston, MA
- 13 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,...
Our client in Western Massachusetts is seeking an e xperienced Core Laboratory Manager. Enjoy a full-time permanent opportunity that offers competitive compensation and excellent benefits. The...
Conducts immunohistochemistry, microscopy, and molecular biology techniques such as sequencing and PCR....
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...
Summary: In collaboration with the Patient Care Director the Clinical Nurse Manager evaluates the delivery of patient care using the organization's quality metrics monitors and reports trends in...
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...
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...
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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
- 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
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Cloning
- Drug Development
- Clinical Laboratory Operations
- Genotyping
- DNA Isolation
- Western Blot
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- 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
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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