Director of Quality Assurance and Regulatory Affairs Jobs in Westford, 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, Quality Assurance GCP
- Xenon Pharmaceuticals Inc.
- Needham, MA (23 miles from Westford, MA)
- 2 hours ago
- Needham, MA (23 miles from Westford, MA)
- 2 hours ago
We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial....
In PersonManager, Quality Assurance Operations
- bluebird bio, Inc.
- Somerville, MA (22 miles from Westford, MA)
- 4 days ago
- Somerville, MA (22 miles from Westford, MA)
- 4 days ago
guidelines), Deviation, CAPA, and investigation processes, Change Control systems and validation lifecycle Knowledge of lentiviral vector process preferred Knowledge of process validation preferred...
In Person- Northeastern University
- Roxbury Crossing, MA (24 miles from Westford, MA)
- 6 days ago
- Roxbury Crossing, MA (24 miles from Westford, 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 PersonExecutive Director, Regulatory Affairs
- Dyne Therapeutics, Inc.
- Waltham, MA (16 miles from Westford, MA)
- 6 days ago
- Waltham, MA (16 miles from Westford, MA)
- 6 days ago
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target...
In PersonAssociate Director Regulatory Affairs
- Viridian Therapeutics Inc.
- Waltham, MA (16 miles from Westford, MA)
- 7 days ago
- Waltham, MA (16 miles from Westford, 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 Person- ThermoFisher Scientific
- Waltham, MA (16 miles from Westford, MA)
- 11 days ago
- Waltham, MA (16 miles from Westford, MA)
- 11 days ago
Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive...
In PersonOpen Rank Clinical Professor and Director of Quality and Regulatory Compliance - School of Nursing
- Northeastern University
- Roxbury Crossing, MA (24 miles from Westford, MA)
- 13 days ago
- Roxbury Crossing, MA (24 miles from Westford, MA)
- 13 days ago
Open Rank Clinical Professor and Director of Quality and Regulatory Compliance - School of Nursing About the Opportunity About Northeastern Founded in 1898, Northeastern is a global research...
In Person- Zealand Pharma U.S., Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 16 days ago
- Cambridge, MA (21 miles from Westford, 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 PersonSr Manager, Quality Assurance CAPA
- Foundation Medicine, Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 22 days ago
- Cambridge, MA (21 miles from Westford, MA)
- 22 days ago
Familiarity withclinical laboratory quality systems (CLIA)and interfaces between laboratory, device, and clinical trial quality....
RemoteInnovation Lab Manager, RDPI - Global Engineering
- Amazon.com Services LLC
- Westborough, MA (23 miles from Westford, MA)
- 30+ days ago
- Westborough, MA (23 miles from Westford, MA)
- 30+ days ago
The RDPI (Robotics Deployment & Packaging Innovation) Global Engineering team is seeking a talented and highly organized Lab Manager to contribute to delivering transformational innovation to the...
In PersonSenior Director Quality Assurance Filtration
- Danaher Corporation
- Marlborough, MA (17 miles from Westford, MA)
- 30+ days ago
- Marlborough, MA (17 miles from Westford, MA)
- 30+ days ago
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danahers 15+ operating companies,...
In PersonAssociate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)
- Intellia Therapeutics
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
- Cambridge, MA (21 miles from Westford, 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 (16 miles from Westford, MA)
- 30+ days ago
- Waltham, MA (16 miles from Westford, MA)
- 30+ days ago
trial design and product labeling as it related to the use of study results in US and global promotion....
In PersonSr. Manager, Regulatory Affairs, CMC
- Alnylam Pharmaceuticals, Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
Qualifications: * Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related field. * Minimum 4-6 years of experience in the pharmaceutical/biotechnology/life...
HybridManager Regulatory Affairs, CMC
- Akebia Therapeutics, Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
- Cambridge, MA (21 miles from Westford, 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 PersonDemographic Data for Westford, MA
Moving to Westford, MA? Find some basic demographic data about Westford, MA below.
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Director of Quality Assurance and Regulatory Affairss in Westford, 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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