Senior Staff, Manufacturing Technical Operations Manager (Contract)

Job Description

This senior-level staff member on the MTO is responsible for complete ownership of quality records including but not limited to Deviations CAPAs Change Controls Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of record ownership triages investigation CAPA and change controls. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines.

KEY RESPONSIBILITIES :

• Triage manufacturing issues in real-time on manufacturing floor.
• Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing quality control material operations and facility operations functional areas.
• Identify and collaborate with SMEs for triage determine immediate actions and containment document initial impact assessments.
• Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
• Own drive and manage CMC CAPAs and change controls from initiation assessment and planning execution and closure.
• Own deviations CAPA Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
• Promote MTO and QA- aligned compliance best practices to further establish operational and quality event record center of excellence teams.
• Other duties and projects as assigned to meet departmental requirements and clinical timelines.

QUALIFICATIONS :

Contract Length : 12 month with the chance to extend

Pay Range

$55 / hr.-$65 / hr.

Shift / Hours

Sunday-Thursday 12 - 8 : 30pm Monday-Friday 12-8 : 30pm and Tuesday-Saturday 12-8 : 30pm

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and / or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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No C2C or Third-Party Vendors

Required Experience :

Manager

Key Skills

Facilities Management,ADMA,Heavy Bus Driving,AXA,Building Services,Courier Delivery

Employment Type : Full-Time

Experience : years

Vacancy : 1