Director of Quality Assurance and Regulatory Affairs Jobs in Waltham, 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.
- Northeastern University
- Roxbury Crossing, MA (9 miles from Waltham, MA)
- 6 days ago
- Roxbury Crossing, MA (9 miles from Waltham, MA)
- 6 days ago
Lab Manager About the Opportunity JOB SUMMARY: The Electronic Lab Manager supports the Mechanical and Industrial Engineering (MIE) Department by ensuring the safe, effective, and reliable...
In PersonAssociate Director Regulatory Affairs
- Viridian Therapeutics Inc.
- Waltham, MA
- 7 days ago
- Waltham, MA
- 7 days ago
Regulatory Operations teams to establish and meet timelines for regulatory submissions Other Regulatory Affairs duties as assigned or as business needs require Bachelor's degree in a science field such as Biology...
In PersonResearch Lab Manager/Technologist - Lieb
- Boston Children's Hospital
- Boston, MA (10 miles from Waltham, MA)
- 12 days ago
- Boston, MA (10 miles from Waltham, MA)
- 12 days ago
Perform routine Mycoplasma tests on cell cultures to detect and prevent contamination....
In Person- Dana-Farber Cancer Institute
- Boston, MA (10 miles from Waltham, MA)
- 16 days ago
- Boston, MA (10 miles from Waltham, MA)
- 16 days ago
Assist in the generation and maintenance of research tools, and have general knowledge of either molecular or computational biology techniques....
In Person- Zealand Pharma U.S., Inc.
- Cambridge, MA (6 miles from Waltham, MA)
- 16 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 16 days ago
Does it excite you to play a leading role in ensuring safe, efficient, laboratory operations? Do you have experience with facilities management in a pharma or biotech setting, including lab...
In Person- Zealand Pharma A/S
- Boston, MA (10 miles from Waltham, MA)
- 17 days ago
- Boston, MA (10 miles from Waltham, MA)
- 17 days ago
Does it excite you to play a leading role in ensuring safe, efficient, laboratory operations? Do you have experience with facilities management in a pharma or biotech setting, including lab...
In PersonSenior Director, Regulatory Affairs
- Bicara Therapeutics Inc
- Boston, MA (10 miles from Waltham, MA)
- 21 days ago
- Boston, MA (10 miles from Waltham, MA)
- 21 days ago
Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies (e.g., Project Optimus, accelerated approval reform), and translate them into actionable strategy....
HybridAssociate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)
- Intellia Therapeutics
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ 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...
RemoteExecutive Director, Regulatory Affairs Advertising & Promotion
- Dyne Therapeutics
- Waltham, MA
- 30+ days ago
- Waltham, MA
- 30+ days ago
trial design and product labeling as it related to the use of study results in US and global promotion....
In PersonManager Regulatory Affairs, CMC
- Akebia Therapeutics, Inc.
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a...
In Person- Harvard University Cambridge
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
biology experimental protocols Demonstrated analytical, logistical and organizational acumen and problem-solving skills Strong technical knowledge and experience in molecular biology, genetics and...
In Person- Kura Oncology, Inc.
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged...
In Person- Harvard University
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
biology experimental protocols Demonstrated analytical, logistical and organizational acumen and problem-solving skills Strong technical knowledge and experience in molecular biology, genetics and...
In Person- Harvard University
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and...
In PersonLAB MANAGER, College of Arts & Sciences, Psychology
- Boston University
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
Please note that this position's intended start date is Monday, June 15th. The Substance Use Mechanisms, Motivations, and Interventions for Teens (SUMMIT) Lab, Department of Psychological and...
In PersonDemographic Data for Waltham, MA
Moving to Waltham, MA? Find some basic demographic data about Waltham, MA below.
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Director of Quality Assurance and Regulatory Affairss in Waltham, 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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