Associate Director - TSMS PAR

Responsibilities

• Support Site Leadership to build a diverse and capable TS/MS organization, with a focus on supporting the areas of device assembly and packaging.
• Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development.
• Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency.
• Determine staffing and resource needs to support site TS/MS requirements. Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Provide technical guidance to the TS/MS group. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for the various operational areas.
• Manage external contracts/resources and project management resources, as needed.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
• Drive control, capability, productivity, and continuous improvement for the process.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
• Serve as technical interface external to the Concord site.
• Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

Qualifications

• BS, MS, or Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Minimum 1 year of management or leadership experience, including leading or working effectively with a cross functional group
• Minimum 5 years of regulated industry experience