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Manufacturing Training & Compliance Manager

Manufacturing Training & Compliance Manager

Posted by Hound
Posting ads for 9 years

Location:Lexington, MA

Responsibilities : Responsible for establishing and directing the Manufacturing Operations training and compliance function at the Lexington Manufacturing facilities. Develops and maintains curriculum and delivers job training programs for manufacturing personnel. Establishes the overall strategy for manufacturing training programs and ensures alignment with our corporate training procedures. Tracks training status of manufacturing personnel. Manufacturing Operations point of contact for coordination of internal audits and regulatory inspections. Coordinates compliance programs with the Quality compliance function. Develop, deliver, and maintain the manufacturing training program for manufacturing operations functions at the Lexington Massachusetts site. Develop and conduct introductory training for new manufacturing hires to introduce them to manufacturing operations - Conduct regular reviews of training documentation to maintain compliance to corporate training requirements - Develop the methodology and tools to track effectiveness of manufacturing training program - Created effective measurements and metrics to report out on training performance and compliance. - Collaborate with other functions and make critical decisions regarding the development and implementation of new training programs - Manage a training support staff (minimum of 1 direct report) who assist with the development, coordination, and management of manufacturing training activities' - Provide technical product training (utilizing both in house or out of house resources) -Training on project management and team building. Compliance: - Manage additional specialists as determined by manufacturing management in the areas of compliance. - Working with the site Quality Compliance function, schedule and coordinate internal audits and regulatory inspections for the manufacturing group. Responsible for leading the closure of applicable audit findings. -Works with manufacturing management to maintain cGMP compliance in the manufacturing area. Develops and tracks corrective measures as needed.

Requirements : BA/BS degree in the sciences with 10 years of experience in a manufacturing environment. Prior experience as a floor supervisor and / or developing, administrating, and managing a training function at a biologics manufacturing facility is preferred. Key Skills and Competencies: Skills: - Strong leadership and communication skills - Working knowledge of instructional design models and methods - Working knowledge of Good Manufacturing Practices, operating procedures including associated equipment. - Working knowledge of assessment methods and tools to evaluate training program effectiveness. Leadership Capabilities (DNA): - Delivering Excellence - Serving Customers - Energy and Drive - Developing Organizational Capability Complexity and Problem Solving: Makes decisions of moderate to high complexity. Accountable for key decisions related directly to development and execution of the Manufacturing Operations training program.

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