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.
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA
- 30+ days ago
- Alameda, CA
- 30+ days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
This position has been deemed critical by the Stanford Doerr School of Sustainability Deans Office and is exempt from the hiring pause. This position is based on Stanfords main campus. Interested...
An established company in the flavor and fragrance industry is seeking an experienced Laboratory Manager to lead its Essential Oils Division. This role focuses on the development and production of...
Director, Regulatory Affairs Medical Writer
- South San Francisco, CA
- 12 hours ago
- South San Francisco, CA
- 12 hours ago
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial...
Ref(LF33) Job Summary: Seeking a Laboratory Manager to oversee daily operations of a hospital laboratory, supervising Clinical Lab Scientists and Lab Assistants. Responsible for maintaining...
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and...
Remote WorkAnatomy and Physiology Student Lab Manager - Federal Work Study
- Dahlonega, GA
- 1 day ago
- Dahlonega, GA
- 1 day ago
Preferred Qualifications Credit for Biology 2251K and 2252K preferred....
Bilingual CMC Regulatory Affairs Manager (12 month contract)
- Mississauga, ON
- 1 day ago
- Mississauga, ON
- 1 day ago
These responsibilities include some of the following Preparation of CMC sections of new registration files (medicines, medical devices, cosmetics & foods), briefing books, clinical trials applications...
are clearly defined and documented.a Proactively resolve issues related to outsourced activities.a Updates and maintains appropriate SOPs for the departments.QualificationsBS or BA in engineering, biology...
Associate Director, Quality Assurance Document Control Management
- Woburn, MA
- 1 day ago
- Woburn, MA
- 1 day ago
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right...
Lab Manager - Microbiology, Biology and Chemistry
- River Forest, IL
- 1 day ago
- River Forest, IL
- 1 day ago
Concordia University Chicago (CUC) invites applications for the position of Laboratory Manager for Microbiology, Biology and Chemistry in the Department of Natural Sciences in the College of Health,...
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 1 day ago
- Gaithersburg, MD
- 1 day ago
The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's...
#ourjacobs #bia #omfs #challengeaccepted Bachelors degree in Chemistry, Biology, or related field from an accredited university or college Eight (8) years experience performing sophisticated analyses...
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA
- 1 day ago
- Cambridge, MA
- 1 day ago
Develop asset-specific Regulatory Development Plans and drive health authority interactions related to clinical trials....
Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
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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
- Mentoring
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Document Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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