Senior Director Quality Assurance

Senior Director, Quality Operations

Charlotte, NC (Onsite)

About the Opportunity

We are seeking an experienced Senior Director, Quality Operations to lead and elevate the Quality organization at a growing pharmaceutical manufacturing facility. This executive leadership role will be responsible for driving 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 has extensive experience supporting FDA inspections, quality systems, laboratory operations, and commercial manufacturing.

What You'll Do

Strategic Quality Leadership

• Lead the site-wide Quality organization, including Quality Assurance, Quality Control, 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.

Quality & Regulatory Compliance

• Ensure adherence to cGMP, FDA, and other applicable 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.

Quality Systems Oversight

• Provide leadership for deviation management, CAPAs, change controls, complaint investigations, and product quality reviews.
• Oversee validation activities and quality documentation systems.
• Ensure processes remain inspection-ready and aligned with industry best practices.

Manufacturing Quality Support

• Partner closely with Manufacturing, Technical Operations, Supply Chain, and Regulatory teams to ensure product quality throughout the product lifecycle.
• Support commercial manufacturing, process improvements, and product commercialization initiatives.
• Lead investigations and resolution efforts for critical quality and compliance issues.

Laboratory Operations Provide executive oversight for:

• Raw material and component testing
• In-process testing
• Finished product release testing
• Stability programs
• Environmental monitoring
• Microbiology laboratory operations

Qualifications

Required

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, Pharmaceutical Sciences, or a 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 manufacturing 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.

Preferred

• Advanced degree (MS, MBA, PharmD, or PhD).
• Experience supporting semi-solid, topical, or complex drug product manufacturing.
• Track record of building scalable quality systems within growing organizations.