Quality Assurance Manager
2 weeks 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 advancing healthcare through the development of innovative pharmaceutical products. Our commitment to quality and compliance drives our mission to enhance lives globally.
Role Overview: The Manager/Sr. Manager of Quality Assurance will be instrumental in establishing and upholding a robust quality assurance framework within Novelstar. This role is pivotal in ensuring adherence to regulatory standards and internal policies while overseeing quality assurance activities.
Key Responsibilities:
- Develop and maintain a comprehensive quality management system that aligns with current Good Manufacturing Practices (cGMP).
- Oversee the standard operating procedures (SOPs) for the Quality unit and ensure compliance across departments.
- Establish and enforce quality standards to guarantee the integrity of products and processes.
- Collaborate with suppliers to define raw material specifications and implement testing protocols.
- Generate and maintain quality documentation, ensuring all procedures are up-to-date and compliant.
- Conduct thorough reviews of CMC documents for cGMP batches and manage the release of raw materials and finished products.
- Prepare detailed quality reports by analyzing data and identifying trends.
- Drive continuous improvement initiatives based on quality metrics.
- Ensure the site is always prepared for inspections and audits, leading internal and external assessments.
- Train and mentor team members on quality systems and compliance standards.
- Investigate and resolve any quality-related issues, implementing corrective actions as necessary.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degrees preferred.
- A minimum of 8 years of experience in a regulated quality environment.
- Proven experience in leading audits and supporting regulatory inspections.
- Strong analytical skills with the ability to interpret complex data and documents.
- Excellent communication and interpersonal skills, with a focus on collaboration.
- Ability to manage multiple priorities in a fast-paced environment.
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 exhaustive of all responsibilities and duties associated with the role.
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