Manager of Quality Assurance and Regulatory Affairs Jobs in Wisconsin
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.
Menasha Corporation Employees, please log-in to your Workday account to apply for positions. ABOUT US (AND OUR EXCITING FUTURE) Menasha Corporation is all about possibilities. Our two businesses,...
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...
The lab also supports novel fluid biomarker research, including assay development....
Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of...
JOB REQUIREMENTS: Job ID: 21804 JOB DETAILS: WORKING TITLE: LabManager - Human Biology UW SYSTEM OFFICIAL TITLE: Laboratory ManagerPOSTING DATE: April 16, 2025 ESSENTIAL JOB FUNCTIONS: This...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, WI
- 17 days ago
- Madison, WI
- 17 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...
Career Opportunities Position Listing Lab Manager - Human Biology Lab Manager - Human Biology On this page Position Information Essential Job Functions What You'll Do Qualifications The Successful...
Position Summary: Position ensures primary accountabilities and essential functions of the QC/QA laboratory are met. This includes but is not limited to lab testing of in-process quality control,...
Director, Quality Assurance Operations Position Summary Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and...
The Position The purpose of this position within the Quality Assurance department is to support on-going development programs for clinical and commercial drug candidates at Arrowhead. A key...
JOB OBJECTIVE: This role provides strategic and operational regulatory leadership for Usona Institute’s psychedelic drug development activities. The Director will guide and oversee the work...
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Manager of Quality Assurance and Regulatory Affairss in Wisconsin 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
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Biotechnology
- Good Laboratory Practice
- 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 Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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