Manager of Quality Assurance and Regulatory Affairs Jobs in Morrisville, NC
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.
- Raleigh, NC (11 miles from Morrisville, NC)
- 7 days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 7 days ago
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Senior Director Regulatory Affairs Pharmacy Automation Platform
- Durham, NC (10 miles from Morrisville, NC)
- 11 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 11 days 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...
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...
- Durham, NC (10 miles from Morrisville, NC)
- 16 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 16 days ago
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...
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...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC (10 miles from Morrisville, NC)
- 30+ days ago
- Durham, NC (10 miles from Morrisville, NC)
- 30+ 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...
Associate Director, Quality Assurance
- Durham, NC (10 miles from Morrisville, NC)
- 30+ days ago
- Durham, NC (10 miles from Morrisville, NC)
- 30+ days ago
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 (10 miles from Morrisville, NC)
- 30+ days ago
- Durham, NC (10 miles from Morrisville, 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...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Research Triangle Park, NC (4 miles from Morrisville, NC)
- 30+ days ago
- Research Triangle Park, NC (4 miles from Morrisville, 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 (11 miles from Morrisville, NC)
- 30+ days ago
- Raleigh, NC (11 miles from Morrisville, 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...
Lab Manager - Biotech Teaching
- Raleigh, NC (11 miles from Morrisville, NC)
- 60+ days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 60+ days ago
The incumbent will need to have working knowledge of biotechnology research materials, equipment, reagents, and mammalian cell culture sterile technique....
Demographic Data for Morrisville, NC
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Morrisville, NC 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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