Director of Quality Assurance and Regulatory Affairs Jobs in Massachusetts
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.
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to...
guidelines for multi-regional trials....
About this opportunity : The Director, Quality Assurance GMP Operations is responsible for quality oversight of the manufacturing process and operations. This includes leading and managing...
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven...
Job Description Summary: Aviagen is hiring highly professional and qualified person for Health Lab Manager Position. The Health Laboratory Manager shall be directly responsible to the Production...
About UMass Amherst The flagship of the Commonwealth, the University of Massachusetts Amherst is a nationally ranked public land-grant research university that seeks to expand educational access,...
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA
- 7 days ago
- Waltham, MA
- 7 days ago
Executive Director, Regulatory Affairs & Quality Assurance. Evident Scientific - 4.1 Waltham, MA Job Details Estimated: $141K - $195K a year 11 hours ago Benefits Health insurance 401(k) Tuition...
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- Marlborough, MA
- 8 days ago
- Marlborough, MA
- 8 days ago
Manager, Regulatory Affairs (IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics Regulatory Affairs team based out of our San...
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
Senior Manager, Quality Assurance Contamination Control and Sterility Assurance (Hybrid)
- Boston, MA
- 26 days ago
- Boston, MA
- 26 days ago
Job Description The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and...
Job summary BostonGene is seeking a Head of Quality Assurance and Regulatory Affairs to spearhead and enhance our regulatory strategy and quality management programs across all laboratory...
Sr. Director, Regulatory Affairs - CMC CMC / Technical Operations Cambridge, MA ID: 25R-19 Full-Time/Regular Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37...
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering...
POSITION SUMMARY : The Lab Manager, reporting to the Associate Director of the Hematology/Oncology Clinical Research Program, is responsible for the receipt, processing, storage, and shipment of...
Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare...
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Director of Quality Assurance and Regulatory Affairss in Massachusetts 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
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Document Management
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Medical Writing
- Microbiology
- Microscopy
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Reporting
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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