Director of Quality Assurance and Regulatory Affairs Jobs in Maryland
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.
About the Position The Research Laboratory Manager supports the Principal Investigator with the execution and maintenance of the research study, and the management of study documentation. The...
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD
- 19 days ago
- Gaithersburg, MD
- 19 days ago
At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines....
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD
- 22 days ago
- Gaithersburg, MD
- 22 days ago
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned...
Regulatory Affairs Manager V (Regulatory Affairs)
- Fort Detrick, MD
- 24 days ago
- Fort Detrick, MD
- 24 days ago
FDA regulations, ICH guidelines)....
Quality Assurance Manager (Quality Assurance Analyst)
- Frederick, MD
- 24 days ago
- Frederick, MD
- 24 days ago
Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to...
Quality Assurance Manager (Quality Assurance Analyst) NEW
- Frederick, MD
- 26 days ago
- Frederick, MD
- 26 days ago
Quality Assurance Manager (Quality Assurance Analyst) Goldbelt Inc Today Secret Unspecified Unspecified IT - QA and Test Frederick, MD (ON-SITE/OFFICE) Overview Goldbelt Professional Services...
walking manufacturing floor, climbing stairs, and lift up to 25lbs Minimum Qualifications Associate's degree or up to 3 years of college or technical school (preferred area of study: Food Science, Biology...
Under limited supervision, delivers of high quality, cost-effective patient care services and administrative management of Pathology services in the Clinical Laboratory and Point of Care Testing....
Job Description As a senior member of the quality assurance team, you will work collaboratively with laboratory personnel and groups throughout the organization to ensure compliance with...
Experimental Mechanics of Materials Test Lab Manager
- Aberdeen Proving Ground, MD
- 90+ days ago
- Aberdeen Proving Ground, MD
- 90+ days ago
Join Us in Making a Difference in the Lives of Those Defending Our Nation! Why SURVICE? Come join the SURVICE Engineering mission to protect, enhance, and enable those who defend the United...
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Maryland
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Maryland 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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