Director of Quality Assurance and Regulatory Affairs Jobs in Waltham, MA
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.
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA (7 miles from Waltham, MA)
- 16 hours ago
- Bedford, MA (7 miles from Waltham, MA)
- 16 hours 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...
- Boston, MA (10 miles from Waltham, MA)
- 18 hours ago
- Boston, MA (10 miles from Waltham, MA)
- 18 hours ago
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...
- Lexington, MA (4 miles from Waltham, MA)
- 1 day ago
- Lexington, MA (4 miles from Waltham, MA)
- 1 day ago
We are seeking a dedicated and experienced Lab Manager to support both the Biology and Chemistry teams by ensuring a safe, efficient, and well-organized working environment. The Lab Manager will...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 3 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 (10 miles from Waltham, MA)
- 4 days ago
- Boston, MA (10 miles from Waltham, MA)
- 4 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 &...
Director, Regulatory Affairs Strategy
- Boston, MA (10 miles from Waltham, MA)
- 6 days ago
- Boston, MA (10 miles from Waltham, MA)
- 6 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives. WHOOP is seeking a...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 8 days ago
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 8 days ago
Sr. Manager, Regulatory Affairs About Climb Bio: Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates...
Associate Director, Quality Assurance - CMC
- Boston, MA (10 miles from Waltham, MA)
- 9 days ago
- Boston, MA (10 miles from Waltham, MA)
- 9 days ago
Seaport Therapeutics is seeking an experienced Associate Director, QA CMC to manage GMP quality assurance activities supporting clinical development programs, ensuring compliance with Good...
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (6 miles from Waltham, MA)
- 11 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 11 days ago
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote Work- Westborough, MA (20 miles from Waltham, MA)
- 12 days ago
- Westborough, MA (20 miles from Waltham, MA)
- 12 days ago
Preferred: Specialized knowledge of niche topics such as cell therapy, cell culture, QC methods, auditing techniques, barcoding, HEPA filtration science, etc....
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (6 miles from Waltham, MA)
- 13 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 13 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
MGH Cardiac Surgery Large Animal Laboratory -- Levine Lab -- Lab Manager
- Boston, MA (10 miles from Waltham, MA)
- 13 days ago
- Boston, MA (10 miles from Waltham, MA)
- 13 days ago
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech...
Senior Manager, Regulatory Affairs (Clinical)
- Boston, MA (10 miles from Waltham, MA)
- 15 days ago
- Boston, MA (10 miles from Waltham, MA)
- 15 days ago
Senior Manager, Regulatory Affairs (Clinical) Req #306 Boston, MA, USA Job Description Posted Wednesday, January 15, 2025 at 4:00 AM Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a...
Senior Manager, Regulatory Affairs
- Cambridge, MA (6 miles from Waltham, MA)
- 17 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 17 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Demographic Data for Waltham, MA
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Director 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 Director of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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