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.
QUALIFICATIONS: Bachelor's degree required in a research related field, with some experience performing molecular biology techniques (e.g. bacterial culture, molecular cloning, human cell culture, DNA...
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...
Director, Regulatory Affairs, Regulatory Science & Execution
- Boston, MA
- 2 days ago
- Boston, MA
- 2 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies...
The Opportunity We are seeking a Quality professional to join our GCP Quality function at Relay Tx. Under the direction of the Senior Director, you will partner with your Clinical Development...
Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare...
About the Job The Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory...
JOB TITLE: Senior Sales Operations AnalystLOCATION: Seaport, Boston, MA (hybrid 3 days in office)DEPARTMENT: Business AnalyticsDATE PREPARED: 04/22/2025 JOB SUMMARY:The Senior Sales Operations...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Cambridge, MA
- 5 days ago
- Cambridge, MA
- 5 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Associate Director/Director, Quality Assurance Operations
- Boston, MA
- 5 days ago
- Boston, MA
- 5 days ago
Company Overview: Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients....
Other desired skills include: Master's degree or higher in life sciences in biochemistry, chemistry, biology (cell/molecular) or related pharmaceutical fields including biochemical engineering....
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA
- 8 days ago
- Bedford, MA
- 8 days 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...
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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA
- 11 days ago
- Cambridge, MA
- 11 days ago
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our...
Remote WorkAssociate Director, Quality Assurance CMO Management (Hybrid)
- Boston, MA
- 11 days ago
- Boston, MA
- 11 days ago
Job Description The Associate Director, Quality Assurance CMO Management is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs) for Cell &...
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Highest Education Level
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
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- 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
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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