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.
Laboratory Operations Manager or Lab Manager in North Carolina
- Winston Salem, NC
- 3 days ago
- Winston Salem, NC
- 3 days ago
New Laboratory Operations Manager at an award winning hospital in North Carolina! This teaching hospital offers a comprehensive list of services including (but not limited to) cancer care,...
Laboratory Manager or Lab Manager at Top Health System
- Salisbury, NC
- 3 days ago
- Salisbury, NC
- 3 days ago
New Laboratory Operations Manager at an award winning hospital in North Carolina! This teaching hospital offers a comprehensive list of services including (but not limited to) cancer care,...
Creo Director, Quality and Regulatory Compliance in Durham , North Carolina JOB DESCRIPTION OVERVIEW The Director, Quality and Regulatory Compliance, will lead a team responsible for delivering...
Sr. Director, Quality Assurance at Heron Therapeutics Cary, NC Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
Associate Director Of Quality Assurance Clinical Operations
- Durham, NC
- 29 days ago
- Durham, NC
- 29 days ago
Applications for this job will be accepted for at least 30 days from 3/21 Keywords: Gene Therapy, Genetic Disorders, Biotechnology, Molecular Biology, Biopharmaceuticals, Quality Assurance, GXP, Veeva...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Burlington, NC. This position will be responsible for overseeing the operations and administration of the clinical laboratory...
Position Summary: Leads and directs all QA activities supporting analytical laboratory operations in a contract manufacturing organization. Responsible for review of certificates of analysis for...
Lecturer/Lab Manager - Applied Engineering Technology
- Greensboro, NC
- 90+ days ago
- Greensboro, NC
- 90+ days ago
The Lecturer/Lab Manger will contribute to teaching and perform instruction-related duties and responsibilities in accordance with the mission, policies, and procedures of the University. Engages...
Regulatory Science Lead (Associate Director of Regulatory Affairs)
- Raleigh, NC
- 90+ days ago
- Raleigh, NC
- 90+ days ago
Make your mark for patients We are looking for a Regulatory Science Lead (Associate Director of Regulatory Affairs) who is a proactive, collaborative, and strategically minded individual to join...
Demographic Data for North Carolina
Moving to North Carolina? Find some basic demographic data about North Carolina below.
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Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Cloning
- Drug Development
- Clinical Laboratory Operations
- Genotyping
- DNA Isolation
- Western Blot
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
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Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
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