Manager of Quality Assurance and Regulatory Affairs Jobs in Brockton, 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 (19 miles from Brockton, MA)
- 12 hours ago
- Boston, MA (19 miles from Brockton, 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 (19 miles from Brockton, MA)
- 1 day ago
- Boston, MA (19 miles from Brockton, MA)
- 1 day ago
cultures of the three labs (Chauhan lab, Yin lab, and Dohlman lab)....
- Boston, MA (19 miles from Brockton, MA)
- 1 day ago
- Boston, MA (19 miles from Brockton, MA)
- 1 day ago
Job Summary The Channing Division of Network Medicine (CDNM) focuses on network medicine and systems biology approaches to complex diseases....
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA (21 miles from Brockton, MA)
- 3 days ago
- Cambridge, MA (21 miles from Brockton, MA)
- 3 days ago
Develop asset-specific Regulatory Development Plans and drive health authority interactions related to clinical trials....
Senior Director, Regulatory Affairs
- Waltham, MA (24 miles from Brockton, MA)
- 4 days ago
- Waltham, MA (24 miles from Brockton, MA)
- 4 days ago
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...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (19 miles from Brockton, MA)
- 4 days ago
- Boston, MA (19 miles from Brockton, 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...
- Bridgewater, MA (8 miles from Brockton, MA)
- 5 days ago
- Bridgewater, MA (8 miles from Brockton, MA)
- 5 days ago
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and...
Associate Director/Director of Regulatory Affairs
- Boston, MA (19 miles from Brockton, MA)
- 6 days ago
- Boston, MA (19 miles from Brockton, 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 (21 miles from Brockton, MA)
- 10 days ago
- Cambridge, MA (21 miles from Brockton, 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 (21 miles from Brockton, MA)
- 11 days ago
- Watertown, MA (21 miles from Brockton, MA)
- 11 days ago
Preferred Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)....
- Watertown, MA (21 miles from Brockton, MA)
- 14 days ago
- Watertown, MA (21 miles from Brockton, 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....
- Boston, MA (19 miles from Brockton, MA)
- 18 days ago
- Boston, MA (19 miles from Brockton, MA)
- 18 days ago
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...
Associate Director, Regulatory Affairs
- Cambridge, MA (21 miles from Brockton, MA)
- 18 days ago
- Cambridge, MA (21 miles from Brockton, MA)
- 18 days ago
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 Director Regulatory Affairs
- Boston, MA (19 miles from Brockton, MA)
- 21 days ago
- Boston, MA (19 miles from Brockton, MA)
- 21 days ago
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...
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Manager of Quality Assurance and Regulatory Affairss in Brockton, 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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