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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 committed to advancing healthcare through the development of innovative pharmaceutical products. Our goal is to provide high-quality generic products and exceptional service to the pharmaceutical industry, striving to enhance the quality of life globally.
Role Overview: The Manager/Sr. Manager, Quality Assurance will be instrumental in establishing and upholding a robust Quality Assurance framework at Novelstar. This role is critical in ensuring compliance with regulatory standards and internal policies. The successful candidate will oversee internal and external audits and support regulatory inspections.
Key Responsibilities:
- Develop and maintain a comprehensive quality management system to ensure compliance with current Good Manufacturing Practices (cGMP).
- Oversee the Standard Operating Procedures (SOP) for the Quality unit and facilitate the review and approval process for SOPs across departments.
- Ensure product quality by implementing and enforcing stringent quality standards and conducting thorough testing of materials and products.
- Establish raw material specifications by collaborating with suppliers and creating effective testing methodologies.
- Maintain and update quality assurance documentation to reflect current practices and regulatory requirements.
- Review and approve critical documents related to cGMP batches, including environmental monitoring and equipment calibration.
- Prepare comprehensive quality reports by analyzing data and identifying trends.
- Manage quality metrics and drive continuous improvement initiatives.
- Ensure the site is always inspection-ready by managing inspection preparedness activities.
- Lead internal and external audits and provide support during health authority inspections.
- Train and mentor staff on Quality Systems and compliance requirements.
- Investigate and resolve Out of Specification (OOS) and Out of Trend (OOT) results, ensuring root causes are identified and corrective actions implemented.
- Participate in change control processes, investigations, and corrective actions as necessary.
- Review and approve validation protocols and reports, ensuring compliance with regulatory standards.
- Monitor changes in the regulatory landscape and ensure timely updates to practices and procedures.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degrees (MBA, MS, or PhD) are 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 assess complex technical documents.
- Excellent interpersonal skills to foster collaborative relationships with internal and external stakeholders.
- Ability to manage multiple priorities in a fast-paced environment.
- Willingness to travel as needed for business purposes.
Compensation: Competitive salary commensurate with experience, along with comprehensive benefits including medical, dental, vision insurance, life insurance, paid time off, and a 401k plan.
Disclaimer: This job description is intended to provide a general overview of the role and responsibilities. It is not an exhaustive list of all duties and skills required for this position.
