Manager of Quality Assurance and Regulatory Affairs Jobs in Maryland
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 - Cmc (Cell Therapy)
- Gaithersburg, MD
- 8 days ago
- Gaithersburg, MD
- 8 days ago
The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell...
Director, Regulatory Affairs, Regulatory Science & Execution
- Gaithersburg, MD
- 20 days ago
- Gaithersburg, MD
- 20 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
Experimental Mechanics of Materials Test Lab Manager
- Aberdeen Proving Ground, MD
- 30+ days ago
- Aberdeen Proving Ground, MD
- 30+ days ago
Join Us in Making a Difference in the Lives of Those Defending Our Nation! Why SURVICE? Come join the SURVICE Engineering mission to protect, enhance, and enable those who defend the United...
Qualifications: BS or BA degree in Biology, Chemistry or other relevant degree. At least 5 years experience in the CRO industry and 3 years supervisory experience or equivalent experience....
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 45+ days ago
- Gaithersburg, MD
- 45+ days 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 C...
You should have: B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science At least 5 years of IVD Regulatory Affairs experience Hands-on experience with 510(k), PMA,...
Manager Quality Assurance Clinical and Pharmacovigilance (PV)
- Germantown, MD
- 60+ days ago
- Germantown, MD
- 60+ days ago
Manager Quality Assurance Clinical and Pharmacovigilance (PV) Job Description Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene...
Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD
- 90+ days ago
- Bethesda, MD
- 90+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Maryland 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
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Animal Models
- Gene Therapy
- ICH Guidelines
- Neurobiology
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Reporting
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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