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Quality Assurance Manager
2 months ago
Position: Manager/Sr. Manager, Quality Assurance
Location: Cranbury, NJ
Department: Quality Assurance and Compliance
Company Overview: Novelstar Pharmaceuticals Inc., a subsidiary of Fosun Pharma, is dedicated to the development of innovative pharmaceutical products and high-quality generics. Our mission is to enhance global healthcare through robust growth and innovation.
Role Overview: The Manager/Sr. Manager, Quality Assurance will be instrumental in establishing and upholding a comprehensive QA system within Novelstar. This role is pivotal in ensuring compliance with regulatory standards and internal policies.
Key Responsibilities:
- Develop and maintain a quality management system that adheres to cGMP regulations.
- Oversee the Standard Operating Procedures (SOP) for the Quality unit and other departments.
- Ensure product quality by implementing and enforcing rigorous quality standards.
- Collaborate with suppliers to establish raw material standards and testing protocols.
- Document quality assurance procedures and maintain up-to-date records.
- Conduct reviews of CMC documents for cGMP batches and manage environmental monitoring.
- Prepare quality reports by analyzing data and identifying trends.
- Drive quality metrics and lead continuous improvement initiatives.
- Ensure readiness for inspections and manage audit processes.
- Train and mentor staff on quality systems and compliance requirements.
- Investigate and resolve Out of Specification (OOS) results with appropriate corrective actions.
- Participate in internal audits and support regulatory inspections.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degrees preferred.
- At least 8 years of experience in a regulated quality environment.
- Proven experience in leading audits and regulatory inspections.
- Strong technical writing and document review skills.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Excellent communication and interpersonal skills.
Compensation: Competitive salary commensurate with experience, along with comprehensive benefits including medical, dental, vision insurance, and retirement plans.
Disclaimer: This job description is intended to provide a general overview of the position and is not an exhaustive list of all responsibilities and qualifications.
