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
- 14 days ago
- New Orleans, LA
- 14 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,...
Westrock Coffee is seeking a skilled and detail oriented Regulatory Affairs Manager to join our Corporate Food safety and Quality Assurance team. This position plays a key role in ensuring that...
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA
- 2 hours ago
- Bedford, MA
- 2 hours ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Site: The Brigham and Women's Hospital, Inc. At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and...
Work with lab safety officer to manage the safety systems/compliance and ensure the Personal Protective Equipment (PPE) is current and available....
We are seeking a dedicated and experienced Lab Manager to support both the Biology and Chemistry teams by ensuring a safe, efficient, and well-organized working environment. The Lab Manager will...
Qualifications - External Education: A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related...
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...
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...
Career Category Quality Job Description Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients...
Labcorp is seeking a Clinical Laboratory Manager to join our team at Ascension Clay county Hospital in Middleburg, FL. This position will be responsible for overseeing the operations and...
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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 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
- Lab Safety
- Next-Generation Sequencing
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- 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
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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