QC Laboratory Operations Lead

TL;DR

QC Laboratory Operations Lead: Managing core Quality Control support functions at a drug product manufacturing facility with an accent on stability programs, sample lifecycle, and laboratory equipment management. Focus on ensuring GMP compliance, data integrity, and operational efficiency through leadership of cross-functional teams and laboratory electronic systems.

Location: On-site in Middletown, DE

Company

hirify.global is a global provider of R&D and manufacturing services for the pharmaceutical and healthcare industries.

What you will do

• Manage the site stability program, including study initiation, sample tracking, and chamber utilization.
• Oversee laboratory sample management operations from receipt through disposal.
• Direct the full lifecycle of laboratory equipment, including qualification, calibration, and maintenance.
• Establish and manage inventory programs for reagents, consumables, and reference standards.
• Serve as business owner for critical laboratory systems like LIMS and CDS to ensure data integrity.
• Lead and develop the Laboratory Operations team, fostering a culture of compliance and operational excellence.

Requirements

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or Engineering.
• Minimum 7 years of GMP pharmaceutical laboratory experience.
• At least 3 years in leadership or supervisory roles.
• Strong understanding of GMP regulations and ALCOA+ data integrity principles.
• Experience with LIMS, CDS, and computerized system compliance.
• Proven ability to manage multiple priorities in a fast-paced manufacturing environment.

Culture & Benefits

• Opportunity to work in a critical role within a global pharmaceutical manufacturing environment.
• Focus on professional development, coaching, and career growth.
• Commitment to operational excellence and continuous improvement.
• Equal Opportunity Employer with a focus on inclusive hiring practices.