Director of Quality Assurance and Regulatory Affairs Jobs in Saint Paul, MN
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
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...
- Minnetonka, MN (17 miles from Saint Paul, MN)
- 14 days ago
- Minnetonka, MN (17 miles from Saint Paul, MN)
- 14 days ago
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create...
Associate Director, Regulatory Affairs
- Eden Prairie, MN (16 miles from Saint Paul, MN)
- 23 days ago
- Eden Prairie, MN (16 miles from Saint Paul, MN)
- 23 days ago
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation....
Associate Director Regulatory Affairs - Vascular (on-site)
- Saint Paul, MN
- 30+ days ago
- Saint Paul, MN
- 30+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Executive Director, Regulatory Affairs
- Minneapolis, MN (9 miles from Saint Paul, MN)
- 45+ days ago
- Minneapolis, MN (9 miles from Saint Paul, MN)
- 45+ days ago
RETROPHIN INC. Executive Director, Regulatory Affairs in Minneapolis , Minnesota Department: 107000 Regulatory Location: USA- Remote Be a part of a global team that is inspired to make a...
Lab Manager (Research Professional 3)
- Minneapolis, MN (9 miles from Saint Paul, MN)
- 45+ days ago
- Minneapolis, MN (9 miles from Saint Paul, MN)
- 45+ days ago
Serve as the lab safety Officer. * Maintain records of data per protocol requirements and submit protocols to IACUC, IBC & IRB * Attend lab meetings for all labs * Contribute to writing/editing manuscripts...
Director, Quality Assurance Programs
- Eden Prairie, MN (16 miles from Saint Paul, MN)
- 60+ days ago
- Eden Prairie, MN (16 miles from Saint Paul, MN)
- 60+ days ago
The Director of Quality Assurance Programs has the responsibility for implementing and maintaining the internal corporate Quality Assurance Programs at Actus Nutrition. This includes Actus owned...
Demographic Data for Saint Paul, MN
Moving to Saint Paul, MN? Find some basic demographic data about Saint Paul, MN below.
Director 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 Director of Quality Assurance and Regulatory Affairs Jobs in Saint Paul, MN
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Saint Paul, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director 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 »