Manager of Quality Assurance and Regulatory Affairs Jobs in Massachusetts
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.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
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....
Job Title: Client Experience Manager - Quality Assurance Location: WM USA - 37 Upton Drive Location Type: Remote Website: Group: When you join Watson-Marlow Fluid Technology Solutions, a part of...
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
- 5 days ago
- Bedford, MA
- 5 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...
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
- 6 days ago
- Bedford, MA
- 6 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...
Position Summary: ultrafocused - Work together to fearlessly uncover new possibilities This leadership role will drive efforts for establishing, assessing, and maintaining compliance to applicable...
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
guidelines for multi-regional trials....
Fulcrum Therapeutics, Inc. ("Fulcrum") [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Boston, MA
- 11 days ago
- Boston, MA
- 11 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Associate Director Regulatory Affairs Job details Salary $175K - $195K Location Boston, Massachusetts Employment type Permanent Discipline Life Sciences Job description Position: Associate...
Your Education & Experience: Bachelor’s Degree in Food Science, Biology, Microbiology, Chemistry, or related field. 5+ years in food manufacturing required, with 3+ years in the Technical and Quality...
Regulatory Strategist - Advanced Therapeutics (Associate Director) Our biotech client is pioneering next-generation regenerative medicine and seeking a Regulatory Expert to lead efforts in...
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Manager 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 Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Continuous Improvement
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Process Development
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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