Manager, Site External Services

Overview

Iovance’s new cell therapy manufacturing facility is growing and Iovance is hiring for several open roles. The tech services organization seeking highly motivated supervisor to join the facility’s tech services team. This role be responsible for ensuring that all externalized operations at the facility with GMP impact comply with cGMP regulations, as well as internal policies and procedures. Specifically contracts and services for GMP cleaning, pest control, and security will be subject to this role’s oversight.

Specific Responsibilities

• Ensures that external services (cleaning, pest control, security) are compliant to cGMPs and facility procedures. This role will monitor and audit cleaning and pest control services on a daily basis.
• Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
• Ensure written and activity based training is effective and current for all external personnel within scope.
• Maintain and report on performance metrics for each external service.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
• Coordinate routine and non-routine service on a daily basis to ensure the site is compliant with cGMP requirements.
• Participates in regulatory audits as site SME for matters related to external services in scope.

Education and Qualifications

• A Bachelor’s Degree in microbiology, biology, engineering, or a related technical discipline.
• At least five years of experience in the pharmaceutical industry.
• Working knowledge of cGMP regulations.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Attention to detail.
• Knowledge of QMS systems is a plus.

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