Senior Director, Quality Operations - Regulatory Excellence

LHH Recruitment Solutions; Charlotte (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

LHH Recruitment Solutions seeks a Senior Director, Quality Operations to lead the Quality organization at a growing pharmaceutical manufacturing facility. This executive leadership role will drive quality strategy, ensuring regulatory compliance, strengthening quality systems, and fostering a culture of continuous improvement across the site.

The ideal candidate brings a proven track record of leading Quality organizations within highly regulated pharmaceutical, biotech, or CDMO environments and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
• 10-15 years of progressive pharmaceutical quality leadership experience.
• Extensive knowledge of FDA regulations, cGMP requirements, and quality systems.
• Demonstrated success leading Quality organizations in pharmaceutical, biotech, or CDMO environments.
• Experience managing regulatory inspections and interactions with health authorities.
• Strong understanding of analytical and microbiological testing within pharmaceutical manufacturing.
• Proven ability to lead cross-functional teams and influence organizational strategy.

Responsibilities

• Lead the site-wide Quality organization, including QA, QC, Quality Systems, and Compliance functions.
• Establish and execute quality strategies that support business objectives and operational excellence.
• Build, mentor, and develop high-performing quality teams.
• Partner with senior leadership to identify and mitigate quality and compliance risks.
• Ensure adherence to cGMP, FDA, and other regulatory requirements.
• Lead preparation for regulatory inspections, audits, and agency interactions.
• Drive site compliance initiatives and continuous improvement efforts.
• Serve as a key decision-maker for quality events, investigations, and risk management activities.
• Provide leadership for deviation management, CAPAs, change controls, and product quality reviews.
• Oversee validation activities and quality documentation systems.
• Ensure processes remain inspection-ready and aligned with industry best practices.
• Partner with Manufacturing, Technical Operations, Supply Chain, and Regulatory teams to ensure product quality throughout the lifecycle.
• Support commercial manufacturing, process improvements, and product commercialization initiatives.
• Lead investigations and resolution efforts for critical quality and compliance issues.
• Provide executive oversight for laboratory operations including raw material testing, in-process testing, finished product release testing, stability programs, and microbiology testing.

Skills

Quality leadership

Regulatory knowledge

Cross-functional leadership

FDA inspections experience

Education

Bachelor's degree in Life Sciences or related

Advanced degree (MS, MBA, PharmD, or PhD)

Job description

LHH Recruitment Solutions seeks a Senior Director, Quality Operations to lead the Quality organization at a growing pharmaceutical manufacturing facility. This executive leadership role will drive quality strategy, ensuring regulatory compliance, strengthening quality systems, and fostering a culture of continuous improvement across the site.

The ideal candidate brings a proven track record of leading Quality organizations within highly regulated pharmaceutical, biotech, or CDMO environments and