Director of Quality Assurance and Regulatory Affairs Jobs in Hopkinton, 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.
MANAGER, QUALITY ASSURANCE in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with...
Manager, Quality Assurance Technical Operations - Investigations
- Devens, MA (21 miles from Hopkinton, MA)
- 8 days ago
- Devens, MA (21 miles from Hopkinton, MA)
- 8 days ago
Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Director, Quality Assurance & Analytics Dana-Farber Cancer Institute
- Brookline, MA (21 miles from Hopkinton, MA)
- 10 days ago
- Brookline, MA (21 miles from Hopkinton, MA)
- 10 days ago
The Director, Quality Assurance and Analytics provides leadership for the Institute?s quality measurement, data analytics, and reporting programs within the department of Quality and Patient...
Remote WorkLab Manager - QC Microbiology - Operations
- Framingham, MA (8 miles from Hopkinton, MA)
- 11 days ago
- Framingham, MA (8 miles from Hopkinton, MA)
- 11 days ago
Job title: Lab Manager - QC Microbiology - Operations Location: Framingham, MA Come join the QC Microbiology Lab in Framingham as a lab manager for QC Micro operations! About the job We deliver...
Director, Quality Assurance & Analytics
- Brookline, MA (21 miles from Hopkinton, MA)
- 12 days ago
- Brookline, MA (21 miles from Hopkinton, MA)
- 12 days ago
Overview The Director, Quality Assurance and Analytics provides leadership for the Institutes quality measurement, data analytics, and reporting programs within the department of Quality and...
Remote WorkAssociate Director Quality Assurance (QA Process and Data Integrity)
- Cambridge, MA (22 miles from Hopkinton, MA)
- 14 days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 14 days ago
processes within their space as well as establishing supportive partnership across the organization where appropriate Other duties as assigned Minimum Requirements: Minimum of a Bachelors degree in Biology...
Senior Director, Regulatory Affairs
- Cambridge, MA (22 miles from Hopkinton, MA)
- 16 days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 16 days ago
Senior Director, Regulatory Affairs Remote or Cambridge, MA Why join us? Parabilis Medicines is a highly distinctive young biopharmaceutical company whose intention is to grow over time into the...
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
- Waltham, MA (18 miles from Hopkinton, MA)
- 25 days ago
- Waltham, MA (18 miles from Hopkinton, MA)
- 25 days ago
Qualifications Required Education: Bachelors Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred....
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner? Pioneering Medicines, an initiative of Flagship...
- Cambridge, MA (22 miles from Hopkinton, MA)
- 45+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 45+ days ago
guidelines; Leading cross-functional product development teams....
Director of Regulatory Affairs
- Watertown, MA (20 miles from Hopkinton, MA)
- 45+ days ago
- Watertown, MA (20 miles from Hopkinton, MA)
- 45+ days ago
Preferred Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)....
Associate Director, Regulatory Affairs Strategy
- Cambridge, MA (22 miles from Hopkinton, MA)
- 60+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 60+ days ago
guidelines and regulations Excellent organizational and communication skills, both written and verbal Ability to work independently as well as part of a team environment Positive attitude, energetic...
Sr. Director, Regulatory Affairs - CMC
- Cambridge, MA (22 miles from Hopkinton, MA)
- 90+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 90+ days ago
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering...
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Director of Quality Assurance and Regulatory Affairss in Hopkinton, 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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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