Manager of Quality Assurance and Regulatory Affairs Jobs in Florham Park, NJ
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.
- New York City, NY (21 miles from Florham Park, NJ)
- 4 days ago
- New York City, NY (21 miles from Florham Park, NJ)
- 4 days ago
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Lab Manager - Resetarits Lab Barnard College
- New York, NY (21 miles from Florham Park, NJ)
- 5 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 5 days ago
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
- New York, NY (21 miles from Florham Park, NJ)
- 7 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 7 days ago
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (21 miles from Florham Park, NJ)
- 7 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 7 days ago
About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by...
Director, Quality Assurance Operations-CAR-T
- Raritan, NJ (18 miles from Florham Park, NJ)
- 7 days ago
- Raritan, NJ (18 miles from Florham Park, NJ)
- 7 days ago
Qualifications - External Education: A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related...
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 12 days ago
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 12 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Associate Manager, Quality Assurance (Visual Inspection)
- New York, NY (21 miles from Florham Park, NJ)
- 16 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 16 days ago
to remove jewelry, make-up and nail adornments when wearing cleanroom attire To be considered for this role you must hold a BA / BS degree in a life sciences discipline or related field (chemistry, biology...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 19 days ago
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 19 days ago
Gilead Sciences, Inc. Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled...
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (13 miles from Florham Park, NJ)
- 19 days ago
- Nutley, NJ (13 miles from Florham Park, NJ)
- 19 days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 20 days ago
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 20 days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 30+ days ago
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 30+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
Senior Manager of Quality Assurance
- Livingston, NJ (3 miles from Florham Park, NJ)
- 30+ days ago
- Livingston, NJ (3 miles from Florham Park, NJ)
- 30+ days ago
Company: Kelly Services Location: Livingston, NJ Career Level: Mid-Senior Level Industries: Recruitment Agency, Staffing, Job Board Description Kelly Science is seeking a Senior Manager of Quality...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 45+ days ago
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 45+ days ago
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 60+ days ago
- Basking Ridge, NJ (10 miles from Florham Park, NJ)
- 60+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and...
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Manager of Quality Assurance and Regulatory Affairss in Florham Park, NJ 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
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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