Manager of Quality Assurance and Regulatory Affairs Jobs in North Carolina
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Senior Director Regulatory Affairs Pharmacy Automation Platform
- Davis, NC
- 1 day ago
- Davis, NC
- 1 day ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Raleigh, NC
- 3 days ago
- Raleigh, NC
- 3 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...
About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary...
Minimum Requirements: Knowledge, Skills, Abilities Bachelor degree in pharmaceutical science, biology, chemistry, engineering or related science. 10 years work experience in pharmaceuticals and/or biologics...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Raleigh, NC
- 7 days ago
- Raleigh, NC
- 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...
Lab Manager for the Department of Chemistry Elon University
- Elon, NC
- 12 days ago
- Elon, NC
- 12 days ago
Lab Manager for the Department of Chemistry Location: Elon University Campus Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours...
Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department:...
About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary...
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...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC
- 27 days ago
- Durham, NC
- 27 days ago
Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing...
Durham, NC Job Details Full-time Estimated: $113K - $148K a year 1 day ago Qualifications Bachelor of Science English 8 years Bachelor's degree Quality control QA/QC Clinical trials Good Clinical Practice...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Durham, NC
- 29 days ago
- Durham, NC
- 29 days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Research Triangle Park, NC
- 30+ days ago
- Research Triangle Park, NC
- 30+ days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
Lab Manager - Food, Bioprocessing & Nutrition Sciences
- Raleigh, NC
- 30+ days ago
- Raleigh, NC
- 30+ days ago
Minimum Education and Experience: Relevant Baccalaureate (4-year) degree in Food Science, Chemistry, Biology, Engineering, or a related field or a bachelors degree plus alternative or equivalent professional...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in North Carolina offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Electrical Engineering
- Employee Development
- 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
- ASQ Certified Quality Auditor
- TrackWise
- 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
- 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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