Quality Assurance Manager

2 weeks ago

Cranbury, New Jersey, United States Novelstar Pharmaceuticals Inc. Full time

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 goal is to be a leader in global healthcare, enhancing lives through our commitment to quality and compliance.

Role Overview: The Manager/Sr. Manager of Quality Assurance will be responsible for overseeing and maintaining a comprehensive quality assurance system at Novelstar. This role ensures that all operations comply with regulatory standards and internal policies. The successful candidate will coordinate internal and external audits and provide support during regulatory inspections.

Key Responsibilities:

  • Establish and uphold a quality management system to ensure compliance with cGMP standards across the manufacturing and analytical facilities.
  • Oversee the development and maintenance of Standard Operating Procedures (SOPs) for the Quality unit and other departments.
  • Implement quality assurance protocols to guarantee the integrity of products and processes.
  • Develop and enforce raw material standards through collaboration with suppliers and the creation of testing methodologies.
  • Maintain comprehensive quality documentation by drafting and revising quality assurance procedures.
  • Ensure adherence to quality assurance policies and regulatory requirements.
  • Review and approve critical documents related to cGMP batches, including environmental monitoring and equipment calibration.
  • Compile and analyze quality reports to identify trends and areas for improvement.
  • Manage quality metrics and drive initiatives for continuous improvement.
  • Ensure readiness for inspections by maintaining an inspection-ready state at all times.
  • Lead and facilitate internal and external audits, providing support during health authority inspections.
  • Train and mentor staff on quality systems and procedures.
  • Investigate and resolve Out of Specification (OOS) and Out of Trend (OOT) results, implementing corrective actions as necessary.
  • Participate in change control processes, investigations, and corrective actions.
  • Review and approve validation protocols and related documentation.
  • Ensure compliance with all local, state, and federal regulations, including FDA and EMA guidelines.
  • Monitor changes in the regulatory landscape to ensure ongoing compliance.
  • Manage the environmental monitoring and qualification of facilities.
  • Oversee the qualification and testing of purified water systems.
  • Ensure timely testing and release of stability samples.
  • Review and maintain inventory management for raw materials and finished products.

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 technical writing and document review skills.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
  • Excellent communication and interpersonal skills.
  • Willingness to travel as needed.

Compensation: Competitive salary commensurate with experience, along with comprehensive benefits including medical, dental, vision insurance, disability and life insurance, paid time off, and a 401k plan.

Disclaimer: This job description is intended to provide a general overview of the position and is not an exhaustive list of all responsibilities and skills required.

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