Director of Quality Assurance and Regulatory Affairs Jobs
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.
Lab Manager - Blood Bank and Transfusion Medicine
- New Orleans, LA
- 2 days ago
- New Orleans, LA
- 2 days ago
We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned,...
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Core Hours: Monday - Friday, 8am-5pm Purpose and Scope The QA Operations Manager is responsible for managing Quality Assurance support for manufacturing operations, focusing on aseptic processing,...
Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of...
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 Candidate...
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Knowledge of the scientific disciplines of genetics, molecular biology, and bioinformatics....
State Police Lab Manager 14 (D/Lieutenant 14) - SSB / FSD / Bridgeport Lab / Firearms & Toolmarks
- Bridgeport, MI
- 15 hours ago
- Bridgeport, MI
- 15 hours ago
Education Possession of a bachelor's degree in forensic science, chemistry, biochemistry, biology, microbiology, or a related pure or applied science....
Requirements Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
MGH Cardiac Surgery Large Animal Laboratory -- Levine Lab -- Lab Manager
- Boston, MA
- 1 day ago
- Boston, MA
- 1 day ago
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech...
Minimum qualifications: 5 years of experience in managing an industry lab (e.g., semiconductor fabrication or hardware research facility). Experience with safety regulations and protocols in a...
HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and...
Remote WorkLabcorp is seeking a Clinical Laboratory Manager to join our team at Ascension St Vincent's Riverside, Jacksonville, Florida. This position will be responsible for overseeing the operations and...
Preferred Skills Masters degree or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred. Work with CROs preferred....
Remote WorkSave 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...
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Director 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 Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Affirmative Action
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Immunology
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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