Supervisor - Quality Management Systems
Our team is working with one of the fastest growing pharmaceutical companies in the industry on a dynamic buildout in New Jersey. The Supervisor of Quality Management Systems (QMS) plays a crucial role in ensuring regulatory compliance by managing audits, training, and quality improvements, supporting Empower Pharmacy's mission to provide affordable, transformative medications.
Key Responsibilities:
- QMS Management: Lead the implementation of the Quality Management System, including conducting audits, managing corrective and preventive actions, investigating nonconformances, and overseeing risk management. Ensure continuous improvement and maintain document control, change control, and training processes.
- Training and Compliance: Coordinate and deliver training on compliance, good documentation practices, and current Good Manufacturing Practices (cGMP). Ensure adherence to quality policies and regulatory standards.
- Audits and Inspections: Conduct internal audits, support regulatory inspections, and participate in cross-functional meetings to uphold quality standards.
- Change Control and SOP Management: Review and approve change controls, improvement initiatives, and projects. Update Standard Operating Procedures (SOPs) and act as a technical liaison.
- Customer Service and Culture: Provide exceptional customer service and promote a culture of compliance and quality in all activities.
Required Knowledge and Skills:
- Regulatory Expertise: In-depth knowledge of sterile aseptic manufacturing, pharmacy regulations, and cGMP
- Leadership and Organization: Strong leadership and organizational abilities.
Experience and Qualifications:
- Educational Background: Bachelor's degree in a life sciences field required; master's degree preferred.
- Industry Experience: Minimum of 3 years in the pharmaceutical industry, with at least 2 years in a supervisory role and 3 years in root cause analysis.
