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.
Assist in the generation and maintenance of research tools, and have general knowledge of either molecular or computational biology techniques....
Preferred Qualifications: Background and interest in mammalian cell culture, molecular biology, handling RNA, and qPCR techniques....
Travel Laboratory Manager Company: Fusion Medical Staffing Location: Facility in Pittsfield, Massachusetts Job Details Fusion Medical Staffing is seeking a skilled Laboratory Manager for a 13 week...
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...
GxP QA Audit and/or Regulatory Inspection experience (GCP experience a plus) Knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Manufacturing and Clinical Practices, ICH...
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...
Director, Quality Assurance & Analytics Dana-Farber Cancer Institute
- Brookline, MA
- 10 days ago
- Brookline, MA
- 10 days ago
The Director, Quality Assurance and Analytics provides leadership for the Institute?s quality measurement, data analytics, and reporting programs within the department of Quality and Patient...
Remote WorkJob 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...
Overview The Director, Quality Assurance and Analytics provides leadership for the Institutes quality measurement, data analytics, and reporting programs within the department of Quality and...
Remote WorkAt AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines....
Senior Director, Regulatory Affairs Employer Proclinical Staffing Location Boston, USA, Massachusetts Salary Negotiable Start date 4 Aug 2025 Closing date 18 Aug 2025 categories Apply now Job...
Associate Director Quality Assurance (QA Process and Data Integrity)
- Cambridge, MA
- 14 days ago
- Cambridge, MA
- 14 days ago
processes within their space as well as establishing supportive partnership across the organization where appropriate Other duties as assigned Minimum Requirements: Minimum of a Bachelors degree in Biology...
The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process for...
Senior Director, Regulatory Affairs Remote or Cambridge, MA Why join us? Parabilis Medicines is a highly distinctive young biopharmaceutical company whose intention is to grow over time into the...
Senior Director Quality Assurance Operations
- Bridgewater, MA
- 18 days ago
- Bridgewater, MA
- 18 days ago
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and...
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Highest Education Level
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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- 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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