Quality Assurance Manager
4 weeks ago
At KMR Search Group, we are seeking a highly skilled and experienced Manager of Quality Assurance to join our team. As a key member of our organization, you will be responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system that supports clinical development and regulatory approval of products.
This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs. You will be responsible for developing, implementing, maintaining, and continually assessing a quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.
Key Responsibilities:- Develop and implement quality assurance policies and standard operating procedures (SOPs) to ensure compliance with regulatory requirements.
- Establish and maintain a document control system for procedures, work instructions, and forms.
- Manage deviation and change control programs to ensure timely and effective resolution of quality issues.
- Assist with executing quality training for the team and provide guidance on quality-related matters.
- Conduct internal quality audits and customer quality audit responses to ensure compliance with regulatory requirements.
- Implement a continuous improvement plan to grow and mature the quality assurance function and quality management system.
- Bachelor's Degree in Biological sciences, Engineering, or related field.
- Minimum of 5 years of experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
- Proven ability to develop, communicate, and gain support for execution plans with team members from other functions.
- Management skills to grow and manage a high-performing quality organization.
- Demonstrated skills in project management and working with vendors and contractors.
- Background in FDA, ISO, EMA, GMP, and ICH requirements ideally for ATMPs.
- Familiar with regulatory submissions and regulatory inspections.
We offer a dynamic and fast-paced work environment that requires management of several competing priorities while driving all projects forward and meeting program/project deliverables. If you are a motivated and results-driven individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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Quality Assurance Manager
3 weeks ago
Boston, Massachusetts, United States KMR Search Group Full timeJob DescriptionThe Quality Assurance Manager is responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system which supports clinical development and regulatory approval of products.This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC...
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Quality Assurance Manager
3 weeks ago
Boston, Massachusetts, United States KMR Search Group Full timeJob Title: Manager of Quality AssuranceAbout the Role:The Manager of Quality Assurance will be responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system that supports clinical development and regulatory approval of products. This role requires extensive interaction with Clinical Operations,...
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