Manager of Quality Assurance and Regulatory Affairs Jobs in Waltham, MA
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.
Manager, Quality Assurance (QA), Global QMS
- Boston, MA (10 miles from Waltham, MA)
- 12 hours ago
- Boston, MA (10 miles from Waltham, MA)
- 12 hours ago
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We...
Research Lab Manager (Yin, Dohlman, Chauhan)
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
cultures of the three labs (Chauhan lab, Yin lab, and Dohlman lab)....
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
Job Summary The Channing Division of Network Medicine (CDNM) focuses on network medicine and systems biology approaches to complex diseases....
Associate Director, Quality Assurance Document Control Management
- Woburn, MA (8 miles from Waltham, MA)
- 3 days ago
- Woburn, MA (8 miles from Waltham, MA)
- 3 days ago
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right...
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
Develop asset-specific Regulatory Development Plans and drive health authority interactions related to clinical trials....
- Salem, MA (19 miles from Waltham, MA)
- 4 days ago
- Salem, MA (19 miles from Waltham, MA)
- 4 days ago
Job Listing ID: 4305996 Job Title: Director Quality Assurance Application Deadline: Open Until FilledJob Location: Salem Date Posted: 07/05/2025Hours Worked Per Week: Not Provided Shift: Not...
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the teams activities from IND-enabling studies and...
Associate Director, Quality Assurance Document Control Management
- Bedford, MA (7 miles from Waltham, MA)
- 4 days ago
- Bedford, MA (7 miles from Waltham, MA)
- 4 days ago
Position Summary: This role will ensure the effective and efficient execution of the electronic document management system (EDMS) and associated document and record management processes at both...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (10 miles from Waltham, MA)
- 4 days ago
- Boston, MA (10 miles from Waltham, MA)
- 4 days ago
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned...
Associate Director/Director of Regulatory Affairs
- Boston, MA (10 miles from Waltham, MA)
- 6 days ago
- Boston, MA (10 miles from Waltham, MA)
- 6 days ago
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
- Cambridge, MA (6 miles from Waltham, MA)
- 10 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 10 days ago
Reviews sections of IND, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements....
Director of Regulatory Affairs
- Watertown, MA (4 miles from Waltham, MA)
- 11 days ago
- Watertown, MA (4 miles from Waltham, MA)
- 11 days ago
Preferred Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)....
Associate Director, Quality Assurance - Facilities Mgmt.
- Bedford, MA (7 miles from Waltham, MA)
- 13 days ago
- Bedford, MA (7 miles from Waltham, MA)
- 13 days ago
Position Summary: ultrainnovative - Tackle rare and dynamic challenges This role will be responsible for Quality Assurance oversight of Facilities Management activities related to internal GMP...
- Watertown, MA (4 miles from Waltham, MA)
- 14 days ago
- Watertown, MA (4 miles from Waltham, MA)
- 14 days ago
Undergraduate/associate degree in biology, related science or equivalent with at least 4-5 years of relevant experience in hospital, academic or industry setting....
Associate Director, Quality Assurance GMP Training Mgmt.
- Bedford, MA (7 miles from Waltham, MA)
- 14 days ago
- Bedford, MA (7 miles from Waltham, MA)
- 14 days ago
Position Summary: ultrafocused - Work together to fearlessly uncover new possibilities This role will provide Quality Assurance oversight for Training Management related to internal GMP operations...
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Manager of Quality Assurance and Regulatory Affairss in Waltham, MA 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
- Mentoring
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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