Manager, Quality Release

Job Description

Job Description

Salary : Overview

We are seeking highly motivated Manager, Quality Release, to join the facilitys Quality Operations team. The Quality Operations team will be responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures. The Manager, Quality Release will work alongside manufacturing, QC, and Supply Chain, helping to ensure that the highest standard of work is performed.

Shift : Tuesday to Saturday from 11PM to 7 : 30AM

Essential Functions and Responsibilities

• Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Manage a team of specialists to meet established targets.
• Manage and support review of batch related production documentation, ensuring resolution of all identified issues prior product disposition.
• Collaborate with internal functions to address all identified issues in a timely manner. Determine if the issue needs to be documented in the Quality System.
• Coordinating release tasks as assigned to the Quality Release team by the schedule.
• Collaborating lot release dates with cross functional teams for clinical release
• Manage lot release schedules with cross functional teams for release.
• Responsible for managing team to build and maintain a compliance-based culture.
• Responsible for performance management, coaching and mentoring, and development of assigned team members.
• Drives continuous improvement by seeking out and implementing operational excellence projects and activities.
• Reports escalations immediately to management that could impact product Quality on release.
• Manage and support disposition of incoming materials and finished product.
• Initiate and review of documentation for release.
• Support generation of Quality Metrics.
• Ensure timely lot closure.
• Support and review deviations, CAPAs, Laboratory Investigations, temperature excursions and other non-conformances.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

Preferred Education, Skills, and Knowledge

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

Mental : Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical / biochemical is possible. Requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individuals race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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