Quality Engineering Manager
Our team is working with one of the fastest growing pharmaceutical companies in the industry on a dynamic Manager of Quality Engineering to lead their quality engineering buildout in New Jersey. This permanent role focuses on establishing robust engineering functions and developing systems to ensure product safety and efficacy. Your expertise will drive us to exceed industry standards through innovative practices.
As the Quality Engineering Manager, you will ensure compliance with regulatory standards, manage quality processes, validation protocols, and investigations, and implement effective Corrective and Preventive Actions (CAPAs). You will collaborate across departments, provide training on Good Manufacturing Practices (cGMP) and data integrity, enhance team skills, manage risks, and maintain audit readiness, all while supporting our mission to deliver cutting-edge healthcare solutions.
Key Responsibilities
- Ensure compliance with USP, FDA, and cGMP standards through audits, inspections, and evaluations of deviations, complaints, and CAPAs.
- Lead investigations into quality deviations and product complaints, implementing CAPAs based on root cause analysis.
- Collaborate with cross-functional teams and external partners to enhance quality systems and provide training on cGMP, data integrity, and compliance.
- Improve team capabilities through training on standards, lead risk assessments, and ensure readiness for regulatory audits.
Required Knowledge and Skills
- Strong leadership and interpersonal skills, with the ability to foster teamwork, work independently, take initiative, and communicate effectively with management.
- Extensive knowledge of FDA regulations, cGMP, and data integrity, along with proficiency in continuous improvement tools (e.g., Six Sigma, lean manufacturing), Microsoft Office Suite, and data analysis using Excel or Minitab.
- Minimum of 7 years of experience in the pharmaceutical industry, including qualification protocols, validations, and root cause analysis, with at least 3 years in a supervisory or managerial role.
- Bachelor's degree in a science or engineering field
This is your chance to join a company that is revolutionizing the pharmaceutical industry. If you are passionate about quality engineering and eager to lead a team towards excellence, they want to hear from you. Apply now to be a part of their innovative journey and help deliver groundbreaking healthcare solutions.
