Job Description

Manager, Quality, Release (Tuesday to Saturday, night shift)

Direct Hire

Salary Range: $120-140k base

Onsite in Philadelphia, PA

Must be a US Citizen

Must have experience managing direct reports

Must have biopharma industry experience

Shift: Tuesday to Saturday from 11PM to 7:30AM (Night Shift)

We are seeking highly motivated Manager, Quality Release, to join the facility’s 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.

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

• Bachelor’s Degree in Science, Engineering, or a related technical discipline.
• A minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; (degree in Science or Engineering) or equivalent experience in a regulated industry.
• Proficient knowledge of cGMP regulations.
• Perform routine activities with minimal oversights.
• Prior experience with review of QC data specific to cell therapy testing.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Extremely detail oriented with strong technical skills.
• Knowledge of MasterControl is preferred.
• High level of accountability and ownership.
• Demonstrate a sense of urgency ability to recognize time sensitivity.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multidisciplined teams.

Preferred Education, Skills, and Knowledge

• Knowledge of QMS systems is a plus.

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

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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