Job Title: Vice President (Quality)

Job Type: Full Time

Location: Somerset, NJ (Onsite)

Job description:

Role Summary

This position is responsible for overall quality function at the site. This position works closely with other organizational functions (Manufacturing, Procurement, RA, R & D, Corporate QA etc.) for ensuring timely support while ensuring Quality & compliance responsibilities.

Essential Duties and Responsibilities:

• Responsible for implementation and compliance of current Good Manufacturing Practices (cGMP), GxP, and any other applicable regulatory requirements, including EH&S requirements.
• Ensure that all operations and activities are executed with adherence to the applicable SOPs.
• Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building.
• Maintain adequate staffing levels and verify that the team members are qualified and meet the job requirements.
• Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements
• Ensuring that goods are produced according to the regulatory filing and / or as per marketing authorization.
• Review of regulatory requirements and its compliance.
• Planning, budgeting and approval of the resources.
• Monitoring and controlling the effective utilization of resources / budget.
• Compilation of Departmental CAPEX budget and expenses control.
• Final authority for release or rejection of materials and products subject to the compliance of the Quality System.
• To conduct self-inspection and / or quality audit that regularly appraises the effectiveness and applicability of the Quality Assurance Systems.
• Ensure investigation for Out of Specification results, OOT, Deviations, Product failures and Market complaints are adequately performed and documented with appropriate corrective and preventive actions based on the results of the investigations are identified and implemented.
• Monitoring the effectiveness of CAPA and Change Controls and their trending.
• Administration & technical support to site investigation team for effectively managing investigation.
• Administration & technical support to site validation team for effectively conducting validation / qualification activities.
• Ensure effective monitoring of the vendor qualification system.
• To ensure that the required initial and continuing training of all department personnel is carried out and adopted according to the need.
• Ensure retention, archival and retrieval of documents and records as per regulatory requirements.
• Ensure that the technical agreement and contract agreement are in place whenever required and ensure its compliance.
• To handle product recalls and product returns.
• Facilitate Regulatory Inspections at the site consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
• Compilation of Regulatory responses and follow-up communications.
• Liaoning with the local FDA.