Director of Quality Assurance and Regulatory Affairs Jobs in Bedford, 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.
Associate Director, Quality Assurance - Facilities Mgmt.
- Bedford, MA
- 1 day ago
- Bedford, MA
- 1 day ago
Position Summary: ultrainnovative - Tackle rare and dynamic challenges This role will be responsible for Quality Assurance oversight of Facilities Management activities related to internal GMP...
- Watertown, MA (10 miles from Bedford, MA)
- 2 days ago
- Watertown, MA (10 miles from Bedford, MA)
- 2 days ago
Undergraduate/associate degree in biology, related science or equivalent with at least 4-5 years of relevant experience in hospital, academic or industry setting....
Associate Director, Quality Assurance GMP Training Mgmt.
- Bedford, MA
- 2 days ago
- Bedford, MA
- 2 days ago
Position Summary: ultrafocused - Work together to fearlessly uncover new possibilities This role will provide Quality Assurance oversight for Training Management related to internal GMP operations...
Position Summary: ultrafocused - Work together to fearlessly uncover new possibilities This leadership role will drive efforts for establishing, assessing, and maintaining compliance to applicable...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Boston, MA (14 miles from Bedford, MA)
- 2 days ago
- Boston, MA (14 miles from Bedford, MA)
- 2 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
- Waltham, MA (7 miles from Bedford, MA)
- 2 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 2 days ago
Direct message the job poster from Sionna Therapeutics Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by...
- Boston, MA (14 miles from Bedford, MA)
- 6 days ago
- Boston, MA (14 miles from Bedford, MA)
- 6 days ago
guidelines for multi-regional trials....
Director, Quality Assurance - R&D
- Boston, MA (14 miles from Bedford, MA)
- 6 days ago
- Boston, MA (14 miles from Bedford, MA)
- 6 days ago
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Boston, MA (14 miles from Bedford, MA)
- 7 days ago
- Boston, MA (14 miles from Bedford, MA)
- 7 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Associate Director Regulatory Affairs
- Boston, MA (14 miles from Bedford, MA)
- 8 days ago
- Boston, MA (14 miles from Bedford, MA)
- 8 days ago
Associate Director Regulatory Affairs Job details Salary $175K - $195K Location Boston, Massachusetts Employment type Permanent Discipline Life Sciences Job description Position: Associate...
Associate Director, Regulatory Affairs
- Boston, MA (14 miles from Bedford, MA)
- 12 days ago
- Boston, MA (14 miles from Bedford, MA)
- 12 days ago
Regulatory Strategist - Advanced Therapeutics (Associate Director) Our biotech client is pioneering next-generation regenerative medicine and seeking a Regulatory Expert to lead efforts in...
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA (11 miles from Bedford, MA)
- 14 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 14 days ago
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, biology...
Associate Director, Regulatory Affairs
- Boston, MA (14 miles from Bedford, MA)
- 14 days ago
- Boston, MA (14 miles from Bedford, MA)
- 14 days ago
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Senior Manager, Regulatory Affairs
- Cambridge, MA (11 miles from Bedford, MA)
- 15 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 15 days ago
What you will do: Acts as regulatory representative on early and late phase clinical studies, ensuring compliant execution of trials Prepares and coordinates regulatory submissions (i.e. clinical trial...
Associate Director, Regulatory Affairs Strategy
- Cambridge, MA (11 miles from Bedford, MA)
- 16 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 16 days ago
trials and marketing authorizations Plan, lead, develop, and review regulatory submissions, such as clinical trial and marketing applications, life-cycle management submissions Plan and lead health...
Demographic Data for Bedford, MA
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Bedford, 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
- Mentoring
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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