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.
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, Regulatory Science & Execution
- Gaithersburg, MD
- 1 day ago
- Gaithersburg, MD
- 1 day 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...
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 6 days ago
- Gaithersburg, MD
- 6 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...
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Manager Quality Assurance Clinical and Pharmacovigilance (PV)
- Germantown, MD
- 28 days ago
- Germantown, MD
- 28 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
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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