Enterprise Operations Director jobs in Gastonia, NC

Position Summary 

The Director of Operations will report to the Executive Director of Operations and provide managerial, technical and quality leadership to the production operations. The incumbent will participate in strategic and technical planning for the Operations group, and will be responsible for establishing manufacturing timelines, executing the plan and monitoring the results

Key Responsibilities 

• Provide guidance and direction to employees and contractors to meet project and support schedules and financial goals while ensuring technical success.
• Responsible for all process and related functions including conceptual design, specifications, budgeting, scheduling, commissioning and start up, to ensure effective implementation
• Develop and maintain strong relationships with technology suppliers and third party contractors
• Lead the coordination of efforts between other teams such as Validation, Manufacturing, Facilities Engineering, Maintenance, Technical Services, R&D, EHS and Regulatory
• Oversee Process identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA)
• Review, analyze and direct capital and expense projects to achieve greater equipment and facility reliability, improve process performance and improve product quality
• Promote holistic or integrative thinking throughout the organization to strengthen collaboration

Experience Requirements  

• Ten (10) years Process Engineering and Leadership experience; preferably in a manufacturing environment 
• Must have 5 years of experience working in FDA regulated pharmaceutical or biotechnology company
• Experience with flexible bag sealing, filling, and packaging equipment, container closure integrity and automated visual inspection
• Demonstrated experience with Process Development, Process Optimization, Scale-up, and Technology Transfers
• Strong understanding of cGMPs and Good Engineering Practices (GEP), Good Automated Manufacturing Practices (GAMP) etc.

Education Requirements  

• Requires a BS/MS in Engineering, or similar degree  or equal experience

EOE including Disability / Veterans