Director of Quality Assurance and Regulatory Affairs Jobs in Devens, 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.
- Hopkinton, MA (21 miles from Devens, MA)
- 7 days ago
- Hopkinton, MA (21 miles from Devens, MA)
- 7 days ago
MANAGER, QUALITY ASSURANCE in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with...
Manager, Quality Assurance Technical Operations - Investigations
- Devens, MA
- 8 days ago
- Devens, MA
- 8 days ago
Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Lab Manager - QC Microbiology - Operations
- Framingham, MA (17 miles from Devens, MA)
- 11 days ago
- Framingham, MA (17 miles from Devens, MA)
- 11 days ago
Job title: Lab Manager - QC Microbiology - Operations Location: Framingham, MA Come join the QC Microbiology Lab in Framingham as a lab manager for QC Micro operations! About the job We deliver...
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
- Waltham, MA (20 miles from Devens, MA)
- 25 days ago
- Waltham, MA (20 miles from Devens, MA)
- 25 days ago
Qualifications Required Education: Bachelors Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred....
Director of Regulatory Affairs
- Watertown, MA (24 miles from Devens, MA)
- 45+ days ago
- Watertown, MA (24 miles from Devens, MA)
- 45+ days ago
Preferred Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)....
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Director of Quality Assurance and Regulatory Affairss in Devens, 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
- Quality Systems
- Implementation
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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