Job Title : Senior QA Manager
Location : New Jersey
About the Role :
We’re seeking a Senior QA Manager to join a fast-paced, growing CDMO in New Jersey. As a Senior QA Manager, you’ll ensure that their products meet the highest quality standards and regulatory requirements.
This is your chance to lead a team of QA professionals and collaborate with cross-functional teams to drive quality initiatives across our manufacturing operations.
Key Responsibilities :
- Manage and mentor a team of QA professionals, fostering a culture of quality and continuous improvement.
- Ensure compliance with FDA, EMA, and other global regulatory standards.
- Oversee the development, implementation, and maintenance of robust quality systems, including CAPA, change control, and risk management.
- Lead internal and external audits, ensuring readiness for regulatory inspections.
- Identify and drive process improvements to enhance product quality and operational efficiency.
- Work closely with R&D, manufacturing, and regulatory teams to ensure seamless integration of quality throughout the product lifecycle.
Qualifications :
- 7+ years of experience in Quality Assurance within the pharmaceutical or biotech industry, with a focus on manufacturing operations.
- Strong working knowledge of phase-appropriate GMP requirements and the ability to present and defend the Quality System to regulatory agencies
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.); advanced degree preferred.
- Proven experience in managing and developing high-performing teams.
- Deep understanding of FDA, EMA, and ICH guidelines and regulations.
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