Manager of Quality Assurance and Regulatory Affairs Jobs
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.
Associate Director, Regulatory Affairs Biologics
- Elanco
- Indianapolis, IN
- 5 hours ago
- Indianapolis, IN
- 5 hours ago
At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm...
In PersonLab Manager, STAT & Physicians Office Labs
- LCH Lab. Corp. of America Holdings
- Birmingham, AL
- 14 hours ago
- Birmingham, AL
- 14 hours ago
Labcorp is seeking a Laboratory Manager to join our team in Birmingham, AL. The territory for this position is Central and North Alabama. The ideal candidate will reside within the territory. This...
In PersonSenior Manager, Regulatory Affairs, Advertising & Promotion
- Regeneron Pharmaceuticals, Inc.
- Warren, NJ
- 15 hours ago
- Warren, NJ
- 15 hours ago
trial recruitment materials, and familiarity with labeling regulations is desirable Ability to influence cross-functional teams and interact with senior management #GDRAJobs Does this sound like you...
In PersonDepartment SSD Institute for Mind and Biology: Staff and Temporary Employees About the Department The Institute for Mind and Biology at the University of Chicago enables research answering fundamental...
In Person- The University of North Carolina At Chapel Hill
- Chapel Hill, NC
- 2 days ago
- Chapel Hill, NC
- 2 days ago
Posting Information Department: Applied Physical Sciences-318100 Career Area: Administrative/Clerical Support Is this an internal only recruitment?: No Posting Open Date : 06/01/2026 Application...
In Person Part TimeLab Manager, STAT & Physician's Office Labs
- LabCorp
- Birmingham, AL
- 2 days ago
- Birmingham, AL
- 2 days ago
Labcorp is seeking a Laboratory Manager to join our team in Birmingham, AL. The territory for this position is Central and North Alabama. The ideal candidate will reside within the territory. This...
In PersonSuccessful leadership in delivering marketing authorizations, clinical trial applications and post-approval submissions for CAR-T and gene therapy products Demonstrated inclusive leadership, emotional...
In PersonLab Manager; Microbiology - Nutrition Manufacturing - Casa Grande AZ
- Casa Grande, AZ
- 2 days ago
- Casa Grande, AZ
- 2 days ago
REQUIRED QUALIFICATIONS Bachelors Degree in Microbiology, Bacteriology, Chemistry, Chemical Engineering, Biology, or other technical degree Minimum 10 years: Experience in nutrition, food or allied...
In Person26-059 Innovation Lab Manager III
- WVU Parkersburg
- Parkersburg, WV
- 3 days ago
- Parkersburg, WV
- 3 days ago
Innovation Lab Manager III Position # 26-059 WVU Parkersburg is a Community and Technical College located in Parkersburg, WV along with Jackson County Center in Ripley, WV and Innovation...
In PersonResearch Lab Manager - Biomedical Engineering
- University of Houston System
- Houston, TX
- 3 days ago
- Houston, TX
- 3 days ago
Department : Biomedical Engineering Salary : $49,400 - $56,200 Description : Supervises and coordinates the activities of personnel engaged in research and experimental testing. Maintains lab...
In PersonI'm hiring for a Assistant Lab Manager in Hawaii! There is potential for sign-on bonus. The Assistant Lab Manager assists with directing supervisory staff and the overall operations of the...
In PersonDirector (Senior Director), Regulatory Affairs
- Shattuck Labs, Inc.
- Durham, NC
- 4 days ago
- Durham, NC
- 4 days ago
Provide oversight of Regulatory staff at CRO executing clinical trials. Provide support to clinical study related activities, including interacting with CROs as needed....
In Person- Fate Therapeutics, Inc.
- San Diego, CA
- 4 days ago
- San Diego, CA
- 4 days ago
Proven experience in applying regulatory knowledge to various clinical activities; strong knowledge of clinical study design, Good Clinical Practice principles, and navigation of clinical development...
In Person- Cytokinetics, Incorporated
- South San Francisco, CA
- 4 days ago
- South San Francisco, CA
- 4 days ago
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new...
HybridLab Manager, Social Origins Lab (Part-time, 9613C) 86527
- HERC
- Berkeley, CA
- 4 days ago
- Berkeley, CA
- 4 days ago
Lab Manager, Social Origins Lab (Part-time, 9613C) 86527 About Berkeley At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels welcome and can...
In Person Part TimeManager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Manager of Quality Assurance and Regulatory Affairs Jobs Nationwide
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 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Oncology
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
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!
Read article »