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.
Overview 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 regulatory...
The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology...
Associate Director, Regulatory Affairs - Cmc (Cell Therapy)
- Gaithersburg, MD
- 20 days ago
- Gaithersburg, MD
- 20 days ago
The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell...
The SRAD offers strategic leadership and has expertise in global regulatory science, drug development processes, and strategies for high-profile programs....
Experimental Mechanics of Materials Test Lab Manager
- Aberdeen Proving Ground, MD
- 45+ days ago
- Aberdeen Proving Ground, MD
- 45+ 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...
Manager Quality Assurance Clinical and Pharmacovigilance (PV)
- Germantown, MD
- 60+ days ago
- Germantown, MD
- 60+ days ago
Partner closely with Clinical and Pharmacovigilance functions to support compliant execution of clinical trials and pre- and post-marketing pharmacovigilance activities....
Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in...
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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
- 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
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biochemistry
- Biology
- Immunology
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- 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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