Manager of Quality Assurance and Regulatory Affairs Jobs in West Chester, PA
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.
Client Experience Manager - Quality Assurance
- Wilmington, DE (19 miles from West Chester, PA)
- 5 days ago
- Wilmington, DE (19 miles from West Chester, PA)
- 5 days ago
Client Experience Manager - Quality Assurance Wilmington, MA, United States of America | req3251 Apply now Posted on: 02/07/2025 - Application Deadline: - Back to Search Job Title: Client...
Associate Director, Quality Assurance
- Elsmere, DE (16 miles from West Chester, PA)
- 9 days ago
- Elsmere, DE (16 miles from West Chester, PA)
- 9 days ago
needed.Planning and scheduling skills, Proven organizational skills, Flexible approach.Goal/results orientated, Starter/Finisher.Education Requirements:Bachelor's degree (or higher) in Chemistry, Biology...
- West Point, PA (22 miles from West Chester, PA)
- 9 days ago
- West Point, PA (22 miles from West Chester, PA)
- 9 days ago
Job Description The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active...
Lab Manager - East Falls (TJU)
- Philadelphia, PA (23 miles from West Chester, PA)
- 10 days ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 10 days ago
Education : A Bachelors Degree in environmental science, chemistry, biology or a related scientific discipline is required, although a Masters Degree is preferred....
Associate Director, Quality Assurance
- Wilmington, DE (19 miles from West Chester, PA)
- 10 days ago
- Wilmington, DE (19 miles from West Chester, PA)
- 10 days ago
Education Requirements: Bachelors degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline....
Principal Scientist (Director) - Regulatory Affairs-CMC
- North Wales, PA (24 miles from West Chester, PA)
- 14 days ago
- North Wales, PA (24 miles from West Chester, PA)
- 14 days ago
Fields of study include Biology, Microbiology, or Biochemistry, Chemical, Mechanical and Electrical Engineering....
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA (16 miles from West Chester, PA)
- 30+ days ago
- Collegeville, PA (16 miles from West Chester, PA)
- 30+ days ago
Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing...
Director, Regulatory Affairs Strategy
- Philadelphia, PA (23 miles from West Chester, PA)
- 45+ days ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 45+ 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...
Your experience and qualifications Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related field and 2 years of experience in the biotech/pharmaceutical industry in...
Demographic Data for West Chester, PA
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Manager of Quality Assurance and Regulatory Affairss in West Chester, PA 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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