Senior Manager, Operations Lead (Assembly and Packaging) (Pharmaceutical)

TL;DR

Senior Manager, Operations Lead (Pharmaceutical): Leading the design, validation, and daily manufacturing operations of device assembly and packaging lines for a new high-volume facility with an accent on cGMP compliance and operational readiness. Focus on transitioning a greenfield site from project phase to routine manufacturing while optimizing production efficiency.

Location: On-site in Holly Springs, North Carolina, USA

Salary: $116,900 - $217,100

Company

hirify.global, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for serious and life-threatening diseases.

What you will do

• Provide scientific and technical leadership for the design, testing, qualification, and validation of device assembly and packaging lines in a new large-volume facility.
• Collaborate with cross-functional teams including Engineering, Quality, and Supply Chain to ensure operational readiness.
• Transition from project-phase leadership to routine daily manufacturing operations following the facility go-live.
• Lead, coach, and develop Process Unit Leads (PULs) and specialists in the Assembly and Packaging areas.
• Develop and optimize plant-level business processes to ensure safe, cost-effective, and efficient operations.
• Drive continuous improvement initiatives using Lean Six Sigma methodologies to increase operating effectiveness.

Requirements

• Bachelor’s degree in a science or engineering discipline.
• 8+ years of progressive experience in the pharmaceutical industry.
• Proven experience in device assembly and packaging operations.
• Strong knowledge of FDA and EMEA guidelines and cGMPs for Manufacturing Parenteral Drug Products.
• Proficiency in validated change management, discrepancy management, and production control systems.
• Must be based in or able to relocate to Holly Springs, North Carolina.

Culture & Benefits

• Opportunity to launch a state-of-the-art "Plant of the Future" from the ground up.
• Fast-paced, entrepreneurial environment with a high level of accountability.
• Relocation benefits provided.
• Discretionary annual bonus based on individual and company performance.
• Comprehensive corporate benefits package.