Hiring: Director Quality Operations Company: LHH Location: Raleigh-Durham-Chapel Hill Area Job Posted Time: 2026-09-11 13:48:29 Employment Type: Contract Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Risk Management, Root Cause Analysis, Stakeholder Management About the job Required Skills: •Lead, mentor, and develop quality teams to create a culture of accountability, collaboration, and operational excellence. Build strong relationships across manufacturing, engineering, supply chain, technical services, validation, and regulatory functions to ensure quality considerations are integrated into business decision-making. •Serve as the primary quality representative during regulatory inspections, customer audits, and external assessments. Lead responses to audit observations, inspection findings, and remediation efforts while maintaining a state of inspection readiness across all quality and manufacturing operations. •Oversee the site's Quality Management System, including deviation management, investigations, CAPA programs, change controls, risk assessments, complaints, and document management processes. Ensure quality systems remain effective, compliant, and aligned with evolving regulatory requirements. •Partner with Quality Control and Microbiology teams to ensure laboratory operations are performed in compliance with established procedures and regulatory requirements. Ensure investigations are thorough, scientifically sound, and supported by effective root cause analysis and corrective actions. •Support supplier quality programs through qualification, auditing, performance monitoring, and ongoing compliance activities. Collaborate with external manufacturing, testing, and service providers to ensure adherence to company quality expectations and regulatory standards. •Drive quality risk management initiatives by leveraging quality metrics, trend analysis, and performance data to identify improvement opportunities. Implement proactive solutions that enhance product quality, strengthen compliance, and improve operational efficiency. •Lead management review activities and provide regular updates to senior leadership regarding quality performance, compliance status, inspection readiness, emerging risks, and continuous improvement efforts. Support technology transfers, process improvements, product launches, and other strategic initiatives as needed. •Ensure all manufacturing, testing, packaging, storage, and distribution activities comply with applicable global regulations, industry standards, and internal quality requirements while maintaining a strong focus on patient safety and product reliability. Qualifications: •A Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, Pharmacy, or a related technical discipline is required. An advanced degree is preferred. •The successful candidate will possess significant progressive leadership experience within pharmaceutical, biotechnology, biologics, medical device, or other highly regulated manufacturing environments. Experience leading Quality Assurance, Quality Control, Quality Systems, and compliance organizations is strongly preferred. •The ideal candidate will have a deep understanding of cGMP regulations, quality systems, validation programs, laboratory operations, manufacturing processes, supplier quality management, and risk management principles. Experience working with contract manufacturing organizations and external suppliers is advantageous. •This position requires a strategic leader who can balance quality, compliance, operational performance, and business objectives while ensuring the consistent delivery of safe, effective, and high-quality products. Compensation: •$230,000 - $240,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!